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Device | Titan Inflatable Penile Prosthesis (IPP) |
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 | S054 |
Date Received | 09/30/2019 |
Decision Date | 07/10/2020 |
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 changing the silicone material used in the components of Titan Penile Prosthesis. |