|
Device | 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 | S034 |
Date Received | 10/23/2013 |
Decision Date | 05/05/2014 |
Product Code |
FHW |
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 AN ADDITIONAL RAW MATERIAL SUPPLIER FOR THE POLYURETHANE SPANDEX MATERIAL USED IN THE FABRICATION OF BIOFLEX® DISPERSION (USED TO MANUFACTURE TITAN RESERVOIRS AND CYLINDERS). |