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 NEOSPHINCTER |
Generic Name | Implanted fecal incontinence device |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P010020 |
Supplement Number | S023 |
Date Received | 04/02/2012 |
Decision Date | 05/02/2012 |
Withdrawal Date
|
12/12/2016 |
Product Code |
MIP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN A MEASUREMENT METHOD USED DURING POST STERILE PACKAGING OPERATION. |
|
|