SURGICEL Powder Absorbable Hemostatic Powder
FDA premarket approval N12159/S069 · decided 2020-09-21
Approval details
- PMA number
- N12159
- Supplement
- S069
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Powder Absorbable Hemostatic Powder
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2020-02-25
- Decision date
- 2020-09-21
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for a second SURGICEL Powder manufacturing area referred to as Suite 2 in the existing Controlled Manufacturing Environment space at the Ethicon LLC, San Lorenzo, Puerto Rico facility.
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