SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat
FDA premarket approval N12159/S088 · decided 2022-03-15
Approval details
- PMA number
- N12159
- Supplement
- S088
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2021-10-01
- Decision date
- 2022-03-15
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for qualification of a new carding suite and addition of duplicate equipment in the Ethicon, LLC, San Lorenzo, Puerto Rico facility.
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