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. |
|
Device | ACTICON NEOSPHINTER |
Generic Name | Implanted fecal incontinence device |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P010020 |
Supplement Number | S017 |
Date Received | 11/15/2010 |
Decision Date | 05/07/2012 |
Withdrawal Date
|
12/12/2016 |
Product Code |
MIP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS. |
|
|