|
Device | COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS |
Generic Name | Device, impotence, mechanical/hydraulic |
Regulation Number | 876.3350 |
Applicant | COLOPLAST CORP. 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 |
PMA Number | P000006 |
Supplement Number | S011 |
Date Received | 08/19/2008 |
Decision Date | 09/16/2008 |
Product Code |
FHW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE ¿SHELF LIFE PROGRAM FOR THE TITAN INFLATABLE PENILE PROSTHESIS ¿ 60 DEGREES C ACCELERATED AND REAL TIME AGING¿ (I.E., SHELF LIFE TESTING PROTOCOL; DOCUMENT ¿MUS 085:065¿), UPDATED TO INCORPORATE THE TEST PARAMETERS FOR THE ONE-TOUCH RELEASE (OTR) PUMP. |