SURGICELTM POWDER Absorbable Hemostatic Powder
FDA premarket approval N12159/S129 · decided 2026-07-28
Approval details
- PMA number
- N12159
- Supplement
- S129
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGICELTM POWDER Absorbable Hemostatic Powder
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2026-03-06
- Decision date
- 2026-07-28
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- for the use of a New Resin and Mold at Alltrista Plastics, an Ethicon, Inc. External Supplier
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