SURGICEL FIBRILLAR Absorbable Hemostat
FDA premarket approval N12159/S073 · decided 2020-09-24
Approval details
- PMA number
- N12159
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGICEL FIBRILLAR Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2020-06-29
- Decision date
- 2020-09-24
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for a line extension for additional size variants within the previously approved size range.
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