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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 | S013 |
Date Received | 11/24/2008 |
Decision Date | 12/22/2008 |
Product Code |
FHW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS. |
Post-Approval Study | Show Report Schedule and Study Progress |