AMS ACTICON NEOSPHINCTER
FDA premarket approval P010020/S031 · decided 2015-04-15
Approval details
- PMA number
- P010020
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMS ACTICON NEOSPHINCTER
- Generic name
- Implanted fecal incontinence device
- Applicant
- Boston Scientific Corp
- Date received
- 2015-03-16
- Decision date
- 2015-04-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.
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|---|---|---|
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
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