[Federal Register Volume 62, Number 141 (Wednesday, July 23, 1997)]
[Notices]
[Pages 39531-39532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0256]
LaserVision Centers, Inc.; Premarket Approval of
LaserVision/VISX Excimer Laser System Model C for
Phototherapeutic Keratectomy (PTK) and Photorefractive Keratectomy
(PRK)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by LaserVision Centers, Inc., St. Louis,
MO, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of the stationary LaserVision/VISX Excimer
Laser System Model C for Phototherapeutic Keratectomy (PTK) and
Photorefractive Keratectomy (PRK). The device is to be manufactured
under an agreement with VISX, Inc., Santa Clara, CA, which has
authorized LaserVision Centers, Inc., to incorporate information
contained in its approved premarket approval applications (PMA's) for
the VISX Excimer Laser System Model C for PTK and for the VISX Excimer
Laser System Model C for PRK. FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of November 15, 1996,
of the approval of the application.
DATES: Petitions for administrative review by August 22, 1997.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. For more information
on the data which supported this application, please refer to the
summary of safety and effectiveness and labeling for the VISX Excimer
Laser System Model C for PTK (under Docket Number 96M-0486) and for the
VISX Excimer Laser System Model C for PRK (under Docket Number 97M-
0084).
FOR FURTHER INFORMATION CONTACT: Morris Waxler, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2018.
SUPPLEMENTARY INFORMATION: On June 3, 1996, LaserVision Centers, Inc.,
St. Louis, MO 63141, submitted to CDRH an application for premarket
approval of the stationary LaserVision/VISX Excimer Laser
System Model C for PTK and PRK. The device is a stationary excimer
laser which delivers pulses at 193 nanometers wavelength. The device is
indicated for PTK in patients with decreased best corrected visual
acuity and/or with disabling pain that are the result of superficial
corneal epithelial irregularities or stromal scars in the anterior one-
third of the cornea. The patients must have failed with alternative
treatment options. For safety, the immediate postoperative corneal
thickness must not be less than 250 microns. Examples of those
conditions that warrant PTK are: (1) Corneal scars and opacity (from
trauma and inactive infections), (2) dystrophies (Reis-Buckler's
granular and lattice), (3) Thygeson's superficial keratitis, (4)
irregular corneal surfaces associated with filamentary keratitis and
Salzmann's nodular degeneration, (5) residual band keratopathy after
unsuccessful ethylene-diamine-tetra-acetic-acid (EDTA) treatment, and
(6) scars subsequent to previous (not concurrent) pterygium excision.
In addition, the device is indicated for PRK for a 6.0 ablation zone in
patients who are myopic and meet all of the following criteria: (1) 1.0
to 6.0 diopters of myopia with astigmatism of < 1.0="" diopters,="" (2)="" refractive="" change="" is="" within="" +="" 0.5="" diopter="" for="" 1="" year="" prior="" to="" the="" laser="" treatment,="" and="" (3)="" 18="" years="" of="" age="" or="" older.="" the="" application="" includes="" authorization="" from="" visx,="" inc.,="" santa="" clara,="" ca="" 95051-0703,="" to="" incorporate="" information="" contained="" in="" its="" approved="" pma's="" for="" visx="" excimer="" laser="" system="" model="" c="" for="" ptk="" and="" for="" the="" visx="" excimer="" laser="" system="" model="" c="" for="" prk.="" in="" accordance="" with="" the="" provisions="" of="" section="" 515(c)(2)="" of="" the="" act="" (21="" u.s.c.="" 360e(c)(2))="" as="" amended="" by="" the="" safe="" medical="" devices="" act="" of="" 1990,="" this="" pma="" was="" not="" referred="" to="" the="" ophthalmic="" devices="" panel="" of="" the="" medical="" devices="" advisory="" committee,="" an="" fda="" advisory="" committee,="" for="" review="" and="" recommendation="" because="" the="" information="" in="" the="" pma="" substantially="" duplicates="" information="" previously="" reviewed="" by="" this="" panel.="" on="" november="" 15,="" 1996,="" cdrh="" approved="" the="" application="" by="" a="" letter="" to="" the="" applicant="" from="" the="" director="" of="" the="" office="" of="" device="" evaluation,="" cdrh.="" a="" summary="" of="" the="" safety="" and="" effectiveness="" data="" on="" which="" cdrh="" based="" its="" approval="" is="" on="" file="" in="" the="" dockets="" management="" branch="" (address="" above)="" and="" is="" available="" from="" that="" office="" upon="" written="" request.="" requests="" should="" be="" identified="" with="" the="" name="" of="" the="" device="" and="" the="" docket="" number="" found="" in="" brackets="" in="" the="" heading="" of="" this="" document.="" opportunity="" for="" administrative="" review="" section="" 515(d)(3)="" of="" the="" act="" authorizes="" any="" interested="" person="" to="" petition,="" under="" section="" 515(g)="" of="" the="" act,="" for="" administrative="" review="" of="" cdrh's="" decision="" to="" approve="" this="" application.="" a="" petitioner="" may="" request="" either="" a="" formal="" [[page="" 39532]]="" hearing="" under="" 21="" cfr="" part="" 12="" of="" fda's="" administrative="" practices="" and="" procedures="" regulations="" or="" a="" review="" of="" the="" application="" and="" cdrh's="" action="" by="" an="" independent="" advisory="" committee="" of="" experts.="" a="" petition="" is="" to="" be="" in="" the="" form="" of="" a="" petition="" for="" reconsideration="" under="" 21="" cfr="" 10.33(b).="" a="" petitioner="" shall="" identify="" the="" form="" of="" review="" requested="" (hearing="" or="" independent="" advisory="" committee)="" and="" shall="" submit="" with="" the="" petition="" supporting="" data="" and="" information="" showing="" that="" there="" is="" a="" genuine="" and="" substantial="" issue="" of="" material="" fact="" for="" resolution="" through="" administrative="" review.="" after="" reviewing="" the="" petition,="" fda="" will="" decide="" whether="" to="" grant="" or="" deny="" the="" petition="" and="" will="" publish="" a="" notice="" of="" its="" decision="" in="" the="" federal="" register.="" if="" fda="" grants="" the="" petition,="" the="" notice="" will="" state="" the="" issue="" to="" be="" reviewed,="" the="" form="" of="" the="" review="" to="" be="" used,="" the="" persons="" who="" may="" participate="" in="" the="" review,="" the="" time="" and="" place="" where="" the="" review="" will="" occur,="" and="" other="" details.="" petitioners="" may,="" at="" any="" time="" on="" or="" before="" august="" 22,="" 1997,="" file="" with="" the="" dockets="" management="" branch="" (address="" above)="" two="" copies="" of="" each="" petition="" and="" supporting="" data="" and="" information,="" identified="" with="" the="" name="" of="" the="" device="" and="" the="" docket="" number="" found="" in="" brackets="" in="" the="" heading="" of="" this="" document.="" received="" petitions="" may="" be="" seen="" in="" the="" office="" above="" between="" 9="" a.m.="" and="" 4="" p.m.,="" monday="" through="" friday.="" this="" notice="" is="" issued="" under="" the="" federal="" food,="" drug,="" and="" cosmetic="" act="" (secs.="" 515(d),="" 520(h)="" (21="" u.s.c.="" 360e(d),="" 360j(h)))="" and="" under="" authority="" delegated="" to="" the="" commissioner="" of="" food="" and="" drugs="" (21="" cfr="" 5.10)="" and="" redelegated="" to="" the="" director,="" center="" for="" devices="" and="" radiological="" health="" (21="" cfr="" 5.53).="" dated:="" june="" 5,="" 1997.="" joseph="" a.="" levitt,="" deputy="" director="" for="" regulations="" policy,="" center="" for="" devices="" and="" radiological="" health.="" [fr="" doc.="" 97-19247="" filed="" 7-22-97;="" 8:45="" am]="" billing="" code="" 4160-01-f="">
