SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat , SURGICEL Fibrillar Absorbable Hemostat,
FDA premarket approval N12159/S087 · decided 2021-10-21
Approval details
- PMA number
- N12159
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat , SURGICEL Fibrillar Absorbable Hemostat,
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2021-09-22
- Decision date
- 2021-10-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Changes to the packaging and Bergami process manufacturing steps related to the addition of automated packaging equipment.
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