SURGICEL
FDA premarket approval N12159/S011 · decided 1989-08-23
Approval details
- PMA number
- N12159
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICEL
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1989-06-16
- Decision date
- 1989-08-23
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
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