SURGICEL Powder
FDA premarket approval N12159/S049 · decided 2018-11-13
Approval details
- PMA number
- N12159
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGICEL Powder
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2018-09-25
- Decision date
- 2018-11-13
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval to modify the post-irradiation Yellowness Index (YI) release specification from <= 42 YI units to <= 49 YI units. The revised release specification of <= 49 YI units still ensures that product will meet the end of shelf life specification of ?68 YI at 18 months.
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