SURGICEL® Absorbable Hemostats
FDA premarket approval N12159/S122 · decided 2025-11-04
Approval details
- PMA number
- N12159
- Supplement
- S122
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGICEL® Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2025-08-07
- Decision date
- 2025-11-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- approval for qualification of the use of the SURGICEL FIBRILLAR (hereafter called as Surgicel Fibrillar) material to produce SURGICEL Powder Absorbable Haemostatic Powder (hereafter called as Surgicel Powder) manufacturing at Ethicon, LLC, San Lorenzo, Puerto Rico facility.
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