ALVEOFORM TM BIOGRAFT

FDA Premarket Approval P860012 S005

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

DeviceALVEOFORM TM BIOGRAFT
Generic NameBone Grafting Material, Animal Source
ApplicantCOLLAGEN CORP.
Date Received1994-11-01
Decision Date1995-03-21
PMAP860012
SupplementS005
Product CodeNPM 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COLLAGEN CORP. 2500 Faber Place palo Alto, CA 94303

Supplemental Filings

Supplement NumberDateSupplement Type
P860012Original Filing
S005 1994-11-01 Normal 180 Day Track
S004 1990-08-31 Special (immediate Track)
S003 1990-01-16 Normal 180 Day Track
S002 1989-12-14 Normal 180 Day Track
S001 1988-11-09 Special (immediate Track)

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