FIBREL

FDA Premarket Approval P850053

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceFIBREL
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMENTOR CORP.
Date Received1985-07-31
Decision Date1988-02-26
Notice Date1988-05-03
PMAP850053
SupplementS
Product CodeLMH 
Docket Number88M-0094
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address MENTOR CORP. 201 Mentor Drive santa Barbara, CA 93111

Supplemental Filings

Supplement NumberDateSupplement Type
P850053Original Filing
S004 1991-06-10 Normal 180 Day Track
S003 1989-01-11 Normal 180 Day Track
S002 1988-07-18 Normal 180 Day Track
S001 1988-06-21 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.