|
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 | S017 |
Date Received | 01/19/2010 |
Decision Date | 07/02/2010 |
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 A NEW DEVICE PRODUCTION MOLD THAT INCORPORATES A TEAR TRIM AND STRAIN RELIEF FEATURE, AS WELL AS MODIFICATIONS TO ASSOCIATED ENGINEERING DRAWINGS AND DIMENSIONAL TOLERANCE SPECIFICATIONS. |