SURGICEL Endoscopic Applicator
FDA premarket approval N12159/S047 · decided 2018-11-21
Approval details
- PMA number
- N12159
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGICEL Endoscopic Applicator
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2018-05-25
- Decision date
- 2018-11-21
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for the addition of the Surgicel Endoscopic Applicator accessory to expand use of the Surgicel Powder Device to endoscopic or laparoscopic procedures.
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