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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 (IPP)
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 NumberS014
Date Received12/12/2008
Decision Date05/29/2009
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN EQUIPMENT USED DURING THE MANUFACTURING DIPPING PROCESS FOR THE DEVICE.
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