SURGICEL Powder Absorbable Hemostats
FDA premarket approval N12159/S116 · decided 2024-12-13
Approval details
- PMA number
- N12159
- Supplement
- S116
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGICEL Powder Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2024-09-16
- Decision date
- 2024-12-13
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- revising the release specification and the extending of the shelf-life
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