|
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 | S024 |
Date Received | 05/02/2011 |
Decision Date | 02/13/2012 |
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 1) A CHANGE IN THE ANGLE OF THE TUBING ON THE CYLINDER FROM THE CURRENT 45 DEGREES TO 0 DEGREES ANGLE TO IMPROVE THE EASE OF IMPLANTATION; AND 2) TO CHANGE THE TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750. |