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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTITAN INFLATABLE PENILE PROSTHESIS
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberP000006
Supplement NumberS029
Date Received12/14/2012
Decision Date01/29/2013
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
Post-Approval StudyShow Report Schedule and Study Progress
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