SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S014 · decided 1995-05-12
Approval details
- PMA number
- N12159
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1995-04-11
- Decision date
- 1995-05-12
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
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