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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
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 NumberS009
Date Received03/11/2008
Decision Date05/23/2008
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE OF ACCELERATED AGING TEMPERATURE FROM 65 DEGREES C TO 60 DEGREES C IN A STABILITY PROTOCOL FOR THE DEVICE.
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