[Federal Register Volume 60, Number 61 (Thursday, March 30, 1995)]
[Notices]
[Pages 16480-16481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7744]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94M-0363]
ExogenTM, Inc.; Premarket Approval of Sonic Accelerated
Fracture Healing System (SAFHS); Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of November 9, 1994 (59 FR
55847). The document announced the approval of the ExogenTM, Inc.,
Sonic Accelerated Fracture Healing System (SAFHS). Some
information was inadvertently omitted and incorrect approval dates were
used. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-2994.
In FR Doc. 94-27222, appearing on page 55847, in the Federal
Register of November 9, 1994, the following corrections are made:
1. On page 55847, in the third column, the ``SUMMARY'' section,
beginning in the 5th line, ``September 13, 1994'' should read ``October
5, 1994''; and in the ``SUPPLEMENTARY [[Page 16481]] INFORMATION''
section in, beginning in the 10th line, the words ``acceleration of the
time to a healed fracture for fresh, closed, distal'' should read ``the
treatment of fresh, closed, posteriorly displaced distal.''
2. On page 55848, in the first column, in the first paragraph, in
the 31st line, after the word ``indication'', the following paragraph
is added:
All other indications for the device will require additional
data, and PMA supplements must be submitted for new indications.
Furthermore, the applicant must conduct a study to gather additional
information to validate some of the conclusions that were drawn from
the PMA studies, based on a larger size.
3. On the same page, in the first column, in the 38th line, after
the word ``review'', the following paragraph is added:
In accordance with the Panel's observation that differences
exist in the rate of healing in different age groups, CDRH also
directed the applicant to include a warning statement regarding the
specific age range of the patients to be treated. CDRH concluded
that based on the study's success criteria (e.g., both
radiographically and clinically healed), the results of study did
show a statistically significant difference in the time to a healed
fracture in favor of the active device.
4. On the same page, in the first column, in the 43d line, after
the word ``panel'' the following phrase is added:
``additional statistical analysis of the patient data stratified
by age and gender,''.
5. On the same page, in the first full paragraph, in the first
line, ``September 13, 1994'' should read ``October 5, 1994''.
Dated: March 17, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-7744 Filed 3-30-95; 8:45 am]
BILLING CODE 4160-01-F
