FIBREL

FDA Premarket Approval P850053 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceFIBREL
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantMENTOR CORP.
Date Received1988-07-18
Decision Date1990-06-27
PMAP850053
SupplementS002
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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

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