SURGICEL Absorbable Hemostat
FDA premarket approval N12159/S050 · decided 2018-11-08
Approval details
- PMA number
- N12159
- Supplement
- S050
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICEL Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2018-10-09
- Decision date
- 2018-11-08
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval to strengthen warnings and precautions in the labeling.
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