|
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 | S098 |
Date Received | 12/05/2013 |
Decision Date | 01/02/2014 |
Product Code |
JCW |
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 PROPOSED ADDITION OF AN ALTERNATIVE METHOD (AUTOMATED) FOR APPLYING A PLUG TO THE KINK RESISTANT TUBING DURING THE MANUFACTURING APPLICATION OF AN ANTIMICROBIAL SURFACE TREATMENT. |