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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 | S029 |
Date Received | 12/14/2012 |
Decision Date | 01/29/2013 |
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 THE FOLLOWING MODIFICATIONS TO THE TITAN NARROW BASECYLINDER (11 AND 14 CM LENGTHS ONLY): (I) CHANGE OF THE ANGLE OF THE TUBING FROM 22.5° TO 0°, AND (II) CHANGE IN CYLINDER TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750. |