ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER
FDA premarket approval P010020/S008 · decided 2008-02-05
Approval details
- PMA number
- P010020
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER
- Generic name
- Implanted fecal incontinence device
- Applicant
- Boston Scientific Corp
- Date received
- 2007-12-26
- Decision date
- 2008-02-05
- Days to decision
- 41 days
- Decision code
- OK30
- Product code
- MIP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- CHANGE TO THE INCOMING INSPECTION CRITERIA FOR A MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.
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