SURGICEL Original Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat,
FDA premarket approval N12159/S086 · decided 2022-07-26
Approval details
- PMA number
- N12159
- Supplement
- S086
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2021-09-07
- Decision date
- 2022-07-26
- Days to decision
- 322 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for labeling changes for SURGICEL Original Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat, including bacteria nomenclature updates and addition of verbiage to bactericidal information, addition of U.S.P statement for oxidized regenerated cellulose, and addition of MRI safety claim.
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