Surgicel Powder Absorbable Hemostatic Powder
FDA premarket approval N12159/S057 · decided 2019-08-14
Approval details
- PMA number
- N12159
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Surgicel Powder Absorbable Hemostatic Powder
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2019-05-16
- Decision date
- 2019-08-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for a change in the colorant of the bellows portion of the device applicator.
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