Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ACTICON NEOSPHINCTER |
Generic Name | Implanted fecal incontinence device |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P010020 |
Supplement Number | S024 |
Date Received | 06/27/2012 |
Decision Date | 09/04/2012 |
Withdrawal Date
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12/12/2016 |
Product Code |
MIP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS ACTICON CONTROL PUMP, A COMPONENT OF THE AMS ACTICON NEOSPHINCTER. |
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