|
Device | AMS 700 SERIES INFATABLE 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 | S097 |
Date Received | 11/26/2013 |
Decision Date | 03/06/2014 |
Product Code |
JCW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO MANUAL INSPECTION METHODS, ADDITION OF AN ALTERNATE AUTOMATED INSPECTION METHOD AND REDEFINITION OF THE DIAMETER MEASUREMENT REGION. |