SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT , SURGICEL® FIBRILLAR, SURGICEL® SNOW)
FDA premarket approval N12159/S085 · decided 2022-01-21
Approval details
- PMA number
- N12159
- Supplement
- S085
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT , SURGICEL® FIBRILLAR, SURGICEL® SNOW)
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2021-09-03
- Decision date
- 2022-01-21
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for the introduction of a new replacement metal detector for detecting metal particles in the cut Oxidized Regenerated Cellulose (ORC) at the San Lorenzo, Puerto Rico manufacturing site.
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