SURGICEL Absorbable Hemostats
FDA premarket approval N12159/S076 · decided 2020-11-12
Approval details
- PMA number
- N12159
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2020-10-15
- Decision date
- 2020-11-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Addition of SURGICEL Original and NU-KNIT Absorbable Hemostats Extra Small (XS) and NU-KNIT Medium (M) sized foil pouches to the upgraded Final Seal Inspection System on the automated Foiling Line (G11719) at the Ethicon SARL, Switzerland site for the inspection of hermetically sealed foil pouches.
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