ACTICON NEOSPHINTER
FDA premarket approval P010020/S017 · decided 2012-05-07
Approval details
- PMA number
- P010020
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Trade name
- ACTICON NEOSPHINTER
- Generic name
- Implanted fecal incontinence device
- Applicant
- Boston Scientific Corp
- Date received
- 2010-11-15
- Decision date
- 2012-05-07
- Days to decision
- 539 days
- Decision code
- APPR
- Product code
- MIP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.
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