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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 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP000006
Supplement NumberS024
Date Received05/02/2011
Decision Date02/13/2012
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1) A CHANGE IN THE ANGLE OF THE TUBING ON THE CYLINDER FROM THE CURRENT 45 DEGREES TO 0 DEGREES ANGLE TO IMPROVE THE EASE OF IMPLANTATION; AND 2) TO CHANGE THE TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.
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