SURGICEL Absorbable Hemostats
FDA premarket approval N12159/S052 · decided 2019-11-26
Approval details
- PMA number
- N12159
- Supplement
- S052
- Supplement type
- 135 Review Track For 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
- 2019-02-21
- Decision date
- 2019-11-26
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for a change to the sampling plan for endotoxin testing.
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