|
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 | S046 |
Date Received | 02/22/2017 |
Decision Date | 05/17/2017 |
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 addition of a new insertion tool; update of pusher tool design; addition of shods supplied with kit; modification of package layout and material; use of new package denesting agent; and 2 year and 5 year shelf-life protocol. |