ALVEOFORM TM BIOGRAFT

FDA Premarket Approval P860012

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

DeviceALVEOFORM TM BIOGRAFT
Generic NameImplant, Endosseous, Root-form
ApplicantCOLLAGEN CORP.
Date Received1986-04-02
Decision Date1988-10-28
Notice Date1989-02-15
PMAP860012
SupplementS
Product CodeDZE 
Docket Number89M-0003
Advisory CommitteeDental
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)

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