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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.
 
Trade NameALPHA I INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Generic Nameinflatable penile prosthesis
Regulation Number876.3350
ApplicantMENTOR CORP.
PMA NumberP000006
Supplement NumberS001
Date Received05/17/2001
Decision Date06/14/2002
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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.
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