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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCOLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Generic Namedevice, impotence, mechanical/hydraulic
Regulation Number876.3350
Applicant
COLOPLAST CORP.
1601 west river road north
minneapolis, 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 Product No
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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