SURGICEL POWDER ABSORBABLE HEMOSTATIC POWDER
FDA premarket approval N12159/S036 · decided 2017-05-26
Approval details
- PMA number
- N12159
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- 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
- 2016-02-08
- Decision date
- 2017-05-26
- Days to decision
- 473 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval or the Surgicel Powder Absorbable Hemostatic Powder as an additional device form of the Surgicel original device.
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