|
Device | ACTICON ARTIFICIAL BOWEL SPHINCTER |
Generic Name | Implanted fecal incontinence device |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P010020 |
Supplement Number | S011 |
Date Received | 09/05/2008 |
Decision Date | 10/09/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITIONAL STERILIZATION UNIT AT THE FACILITY. |