SURGICEL® Absorbable Hemostats
FDA premarket approval N12159/S107 · decided 2023-11-01
Approval details
- PMA number
- N12159
- Supplement
- S107
- 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
- 2023-09-29
- Decision date
- 2023-11-01
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- replacement of manual visual inspection with an automatic seal inspection machine in the Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility
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