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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.
 
DeviceCOLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP000006
Supplement NumberS011
Date Received08/19/2008
Decision Date09/16/2008
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 CHANGES TO THE ¿SHELF LIFE PROGRAM FOR THE TITAN INFLATABLE PENILE PROSTHESIS ¿ 60 DEGREES C ACCELERATED AND REAL TIME AGING¿ (I.E., SHELF LIFE TESTING PROTOCOL; DOCUMENT ¿MUS 085:065¿), UPDATED TO INCORPORATE THE TEST PARAMETERS FOR THE ONE-TOUCH RELEASE (OTR) PUMP.
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