INSTAT COLLAGEN ABSORBABLE HEMOSTAT
FDA premarket approval P830079/S010 · decided 1990-08-28
Approval details
- PMA number
- P830079
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSTAT COLLAGEN ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1990-05-25
- Decision date
- 1990-08-28
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
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