J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT
FDA premarket approval P830079/S007 · decided 1989-08-28
Approval details
- PMA number
- P830079
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1988-09-26
- Decision date
- 1989-08-28
- Days to decision
- 336 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
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