SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT, SURGICEL® POWDER)
FDA premarket approval N12159/S100 · decided 2023-02-28
Approval details
- PMA number
- N12159
- Supplement
- S100
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT, SURGICEL® POWDER)
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2023-01-30
- Decision date
- 2023-02-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Adding a duplicate cutter equipment for increasing manufacturing capacity due to the transfer of Neuchatel Surgicel fabric and Interceed device manufacturing to Ethicon, LLC, San Lorenzo in Puerto Rico.
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