SURGICEL® Absorbable Hemostats
FDA premarket approval N12159/S096 · decided 2022-12-20
Approval details
- PMA number
- N12159
- Supplement
- S096
- 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
- 2022-11-21
- Decision date
- 2022-12-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site.
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