February 08 2013, at 12:00 AM Eastern Standard Time
Start-End Page:
9349 - 9353
Page Count:
5
Comment Start Date:
February 8 2013, at 12:00 AM Eastern Standard Time
Comment Due Date:
May 9 2013, at 11:59 PM Eastern Standard Time
Attachments:
Ref 10 Seiff_ S_ R_ J_ H_ Sullivan_ L_ N_ and J. Ahn_ Pretarsal Fixation of Gold Freeman Weights in Facial Nerve Palsy
View Attachment:
Title: Ref 10 Seiff_ S_ R_ J_ H_ Sullivan_ L_ N_ and J. Ahn_ Pretarsal Fixation of Gold Freeman Weights in Facial Nerve Palsy
Ref 11 Kartush_ J_ M_C_ J. Linstrom_ P_ M_ McCann_ and M_ D_ Graham_ Early Gold Weight Eyelid Implantation for Facial Paralysis
View Attachment:
Title: Ref 11 Kartush_ J_ M_C_ J. Linstrom_ P_ M_ McCann_ and M_ D_ Graham_ Early Gold Weight Eyelid Implantation for Facial Paralysis
Ref 13 Silver_ A_ L_ R_ W_ Lindsay_ M_ L_ Cheney_ and T_ A_ Hadlock Thin_Profile Platinum Eyelid Weighting A Superior Option in the Paralyzed Eye
View Attachment:
Title: Ref 13 Silver_ A_ L_ R_ W_ Lindsay_ M_ L_ Cheney_ and T_ A_ Hadlock Thin_Profile Platinum Eyelid Weighting A Superior Option in the Paralyzed Eye
Ref 14 Schrom_ T_ A_ Loch_ M. Ho_ lzl_ and H_ Scherer_ Abstract Evaluation of a New Lid Implant for Rehabilitation of the Paralyzed Eye
View Attachment:
Title: Ref 14 Schrom_ T_ A_ Loch_ M. Ho_ lzl_ and H_ Scherer_ Abstract Evaluation of a New Lid Implant for Rehabilitation of the Paralyzed Eye
Ref 15 Zwick_ O_ M_ and S_ R_ Seiff_ ‘Supportive Care of Facial Nerve Palsy with Temporary External Eyelid Weights
View Attachment:
Title: Ref 15 Zwick_ O_ M_ and S_ R_ Seiff_ ‘Supportive Care of Facial Nerve Palsy with Temporary External Eyelid Weights
Ref 16 Williams_ Z_ R_ and J_ V_ Aquavella_
Management of Exposure KeratopathyAssociated with Severe Craniofacial Trauma
View Attachment:
Title: Ref 16 Williams_ Z_ R_ and J_ V_ Aquavella_
Management of Exposure KeratopathyAssociated with Severe Craniofacial Trauma
Ref 17 Gautam_ P_ R_ K_ Adhikari_ and B_ R_
Sharma_ A Profile of Eye_Lid Conditions Requiring Reconstruction
Among the Patients Attending an Oculoplasty Clinic in Mid-Western Region of Nepal
View Attachment:
Title: Ref 17 Gautam_ P_ R_ K_ Adhikari_ and B_ R_
Sharma_ A Profile of Eye_Lid Conditions Requiring Reconstruction
Among the Patients Attending an Oculoplasty Clinic in Mid-Western Region of Nepal
Ref 18 Heier_ J_ S_ R_ W_ Enzenauer_ S_ F_
Wintermeyer_ M_ Delaney_ and F_ P_ LaPiana, ‘‘Ocular Injuries and Diseases at
a Combat Support Hospital in Support of Operations Desert Shield and Desert
Storm,
View Attachment:
Title: Ref 18 Heier_ J_ S_ R_ W_ Enzenauer_ S_ F_
Wintermeyer_ M_ Delaney_ and F_ P_ LaPiana, ‘‘Ocular Injuries and Diseases at
a Combat Support Hospital in Support of Operations Desert Shield and Desert
Storm,
Ref 19 Mader_ T_ H_ J_ V_ Aragones_ A_ C_
Chandler_ J_ A_ Hazlehurst_ J_ Heier_ J_ D_ Kingham and E_ Stein Ocular and Ocular Adnexal Injuries Treated by United States Military Ophthalmologists During Operations Desert Shield and Desert Storm
View Attachment:
Title: Ref 19 Mader_ T_ H_ J_ V_ Aragones_ A_ C_
Chandler_ J_ A_ Hazlehurst_ J_ Heier_ J_ D_ Kingham and E_ Stein Ocular and Ocular Adnexal Injuries Treated by United States Military Ophthalmologists During Operations Desert Shield and Desert Storm
Ref 1-Transcript from FDA Ophthalmic Devices Panel Meeting January 13 and 14 2000
View Attachment:
Title: Ref 1-Transcript from FDA Ophthalmic Devices Panel Meeting January 13 and 14 2000
Ref 2 Seiff_ S_ R_ M_ Boerner and S_ R_ Treatment of Facial Palsies With Carter External Eyelid Weights
View Attachment:
Title: Ref 2 Seiff_ S_ R_ M_ Boerner and S_ R_ Treatment of Facial Palsies With Carter External Eyelid Weights
Ref 20 Morley_ M_ G_ J_ K._Nguyen_ J_ S_ Heier_B_ J_Shingleton, J_ F_ Pasternak, and K_S_ Bower_ Blast Eye Injuries A Reviewfor First Responders
View Attachment:
Title: Ref 20 Morley_ M_ G_ J_ K._Nguyen_ J_ S_ Heier_B_ J_Shingleton, J_ F_ Pasternak, and K_S_ Bower_ Blast Eye Injuries A Reviewfor First Responders
Ref 21Blozan_ C_ F_ and S_ A_ Tucker_
Premarket Notifications The First 24,000
View Attachment:
Title: Ref 21Blozan_ C_ F_ and S_ A_ Tucker_
Premarket Notifications The First 24,000
Ref 22 U_S_ Department of Commerce Bureau of Economic Analysis, National Income and Product Accounts Table 1_1_9 ImplicitPrice Deflators for Gross Domestic Product
View Attachment:
Title: Ref 22 U_S_ Department of Commerce Bureau of Economic Analysis, National Income and Product Accounts Table 1_1_9 ImplicitPrice Deflators for Gross Domestic Product
Ref 23 Geiger_ D._R_ FY 2003 and 2004 Unit
Costs for the Process of Medical Device Review
View Attachment:
Title: Ref 23 Geiger_ D._R_ FY 2003 and 2004 Unit
Costs for the Process of Medical Device Review
Ref 3 Neuman_ A_ R_ A_ Weinberg_ M_ Sela_ I_ J_ Peled_ and M_ R_ Wexler_ The Correction of Seventh Nerve Palsy Lagophthalmos With Gold Lid Load 16
Years Experience
View Attachment:
Title: Ref 3 Neuman_ A_ R_ A_ Weinberg_ M_ Sela_ I_ J_ Peled_ and M_ R_ Wexler_ The Correction of Seventh Nerve Palsy Lagophthalmos With Gold Lid Load 16
Years Experience
Ref 4 Kelley_S_ A_ and D_ T_ Sharpe_ Gold Eyelid Weights in Patients With Facial Palsy
View Attachment:
Title: Ref 4 Kelley_S_ A_ and D_ T_ Sharpe_ Gold Eyelid Weights in Patients With Facial Palsy
Ref 5 Jobe_ R_ Gold Lid Loads
View Attachment:
Title: Ref 5 Jobe_ R_ Gold Lid Loads
Ref 6 Pickford_ M_ A_ T_ Scamp_ and D_ H_ Harrison Morbidity After Gold Weight Insertion Into the Upper Eyelid in Facial Palsy
View Attachment:
Title: Ref 6 Pickford_ M_ A_ T_ Scamp_ and D_ H_ Harrison Morbidity After Gold Weight Insertion Into the Upper Eyelid in Facial Palsy
Ref 7 Patel_ B_ C_ P_ Flaharty_ and R_ L_ Anderson ‘Morbidity After Gold Weight Insertion
View Attachment:
Title: Ref 7 Patel_ B_ C_ P_ Flaharty_ and R_ L_ Anderson ‘Morbidity After Gold Weight Insertion
Ref 8 Jobe_ R_ The Use of Gold Weights in the Upper Eyelid
View Attachment:
Title: Ref 8 Jobe_ R_ The Use of Gold Weights in the Upper Eyelid
Ref 9 Chapman_ P_ and B_ G_ Lamberty_ Results of Upper Lid Loading in the Treatment of Lagophthalmos Caused by Facial Palsy
View Attachment:
Title: Ref 9 Chapman_ P_ and B_ G_ Lamberty_ Results of Upper Lid Loading in the Treatment of Lagophthalmos Caused by Facial Palsy
Ref12 Townsend_ D_ J_ Eyelid Reanimation for the Treatment of Paralytic Lagophthalmos Historical Perspectives and Current Applications of the Gold Weight Implant
View Attachment:
Title: Ref12 Townsend_ D_ J_ Eyelid Reanimation for the Treatment of Paralytic Lagophthalmos Historical Perspectives and Current Applications of the Gold Weight Implant
Medical Devices; Ophthalmic Devices: Classification of the Eyelid Weight
Details Information
Attachments:
Ref 10 Seiff_ S_ R_ J_ H_ Sullivan_ L_ N_ and J. Ahn_ Pretarsal Fixation of Gold Freeman Weights in Facial Nerve Palsy
View Attachment:Ref 11 Kartush_ J_ M_C_ J. Linstrom_ P_ M_ McCann_ and M_ D_ Graham_ Early Gold Weight Eyelid Implantation for Facial Paralysis
View Attachment:Ref 13 Silver_ A_ L_ R_ W_ Lindsay_ M_ L_ Cheney_ and T_ A_ Hadlock Thin_Profile Platinum Eyelid Weighting A Superior Option in the Paralyzed Eye
View Attachment:Ref 14 Schrom_ T_ A_ Loch_ M. Ho_ lzl_ and H_ Scherer_ Abstract Evaluation of a New Lid Implant for Rehabilitation of the Paralyzed Eye
View Attachment:Ref 15 Zwick_ O_ M_ and S_ R_ Seiff_ ‘Supportive Care of Facial Nerve Palsy with Temporary External Eyelid Weights
View Attachment:Ref 16 Williams_ Z_ R_ and J_ V_ Aquavella_ Management of Exposure KeratopathyAssociated with Severe Craniofacial Trauma
View Attachment:Ref 17 Gautam_ P_ R_ K_ Adhikari_ and B_ R_ Sharma_ A Profile of Eye_Lid Conditions Requiring Reconstruction Among the Patients Attending an Oculoplasty Clinic in Mid-Western Region of Nepal
View Attachment:Ref 18 Heier_ J_ S_ R_ W_ Enzenauer_ S_ F_ Wintermeyer_ M_ Delaney_ and F_ P_ LaPiana, ‘‘Ocular Injuries and Diseases at a Combat Support Hospital in Support of Operations Desert Shield and Desert Storm,
View Attachment:Ref 19 Mader_ T_ H_ J_ V_ Aragones_ A_ C_ Chandler_ J_ A_ Hazlehurst_ J_ Heier_ J_ D_ Kingham and E_ Stein Ocular and Ocular Adnexal Injuries Treated by United States Military Ophthalmologists During Operations Desert Shield and Desert Storm
View Attachment:Ref 1-Transcript from FDA Ophthalmic Devices Panel Meeting January 13 and 14 2000
View Attachment:Ref 2 Seiff_ S_ R_ M_ Boerner and S_ R_ Treatment of Facial Palsies With Carter External Eyelid Weights
View Attachment:Ref 20 Morley_ M_ G_ J_ K._Nguyen_ J_ S_ Heier_B_ J_Shingleton, J_ F_ Pasternak, and K_S_ Bower_ Blast Eye Injuries A Reviewfor First Responders
View Attachment:Ref 21Blozan_ C_ F_ and S_ A_ Tucker_ Premarket Notifications The First 24,000
View Attachment:Ref 22 U_S_ Department of Commerce Bureau of Economic Analysis, National Income and Product Accounts Table 1_1_9 ImplicitPrice Deflators for Gross Domestic Product
View Attachment:Ref 23 Geiger_ D._R_ FY 2003 and 2004 Unit Costs for the Process of Medical Device Review
View Attachment:Ref 3 Neuman_ A_ R_ A_ Weinberg_ M_ Sela_ I_ J_ Peled_ and M_ R_ Wexler_ The Correction of Seventh Nerve Palsy Lagophthalmos With Gold Lid Load 16 Years Experience
View Attachment:Ref 4 Kelley_S_ A_ and D_ T_ Sharpe_ Gold Eyelid Weights in Patients With Facial Palsy
View Attachment:Ref 5 Jobe_ R_ Gold Lid Loads
View Attachment:Ref 6 Pickford_ M_ A_ T_ Scamp_ and D_ H_ Harrison Morbidity After Gold Weight Insertion Into the Upper Eyelid in Facial Palsy
View Attachment:Ref 7 Patel_ B_ C_ P_ Flaharty_ and R_ L_ Anderson ‘Morbidity After Gold Weight Insertion
View Attachment:Ref 8 Jobe_ R_ The Use of Gold Weights in the Upper Eyelid
View Attachment:Ref 9 Chapman_ P_ and B_ G_ Lamberty_ Results of Upper Lid Loading in the Treatment of Lagophthalmos Caused by Facial Palsy
View Attachment:Ref12 Townsend_ D_ J_ Eyelid Reanimation for the Treatment of Paralytic Lagophthalmos Historical Perspectives and Current Applications of the Gold Weight Implant
View Attachment:See Reference 13
View Attachment:Comments
Submitter: Ronald Posted: 05/20/2013 ID: FDA-2013-N-0069-0002
May 09,2013 11:59 PM ET
Submitter: Eileen Posted: 05/20/2013 ID: FDA-2013-N-0069-0003
May 09,2013 11:59 PM ET
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