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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.
 
DeviceALPHA I INFLATABLE PENILE PROSTHESIS
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberP000006
Supplement NumberS001
Date Received05/17/2001
Decision Date06/14/2002
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR HYDROPHILIC COATING OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR ALPHA 1 INFLATABLE PENILE PROSTHESIS WITH HYDROPHILIC COATING AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
Post-Approval StudyShow Report Schedule and Study Progress
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