SURGICEL Powder
FDA premarket approval N12159/S066 · decided 2019-11-19
Approval details
- PMA number
- N12159
- Supplement
- S066
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Powder
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2019-10-23
- Decision date
- 2019-11-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Add a duplicate Analyzer which has the same functionality and will operate within the same specifications as the existing Analyzer that is already in use for the manufacture of Surgicel Powder.
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