AMS ACTICON NEOSPHINCTER
FDA premarket approval P010020 · decided 2001-12-18
Approval details
- PMA number
- P010020
- Trade name
- AMS ACTICON NEOSPHINCTER
- Generic name
- Implanted fecal incontinence device
- Applicant
- Boston Scientific Corp
- Date received
- 2001-03-30
- Decision date
- 2001-12-18
- Days to decision
- 263 days
- Decision code
- APWD
- Product code
- MIP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR THE AMS ACTICON NEOSPHINCTER SYSTEM. THIS DEVICE IS INDICATED TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOT CANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.
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