MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
FDA premarket approval P800002/S008 · decided 1992-01-07
Approval details
- PMA number
- P800002
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 1991-10-16
- Decision date
- 1992-01-07
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
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