|
Device | AMS 700 INFLATABLE PENILE PROSTHESIS |
Generic Name | Prosthesis, penis, inflatable |
Regulation Number | 876.3350 |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | N970012 |
Supplement Number | S083 |
Date Received | 11/17/2010 |
Decision Date | 05/07/2012 |
Product Code |
JCW |
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 CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS. |