SURGICEL® Absorbable Hemostats
FDA premarket approval N12159/S106 · decided 2023-11-14
Approval details
- PMA number
- N12159
- Supplement
- S106
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICEL® Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2023-08-22
- Decision date
- 2023-11-14
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.
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