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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.
Classification Namedevice, impotence, mechanical/hydraulic
Generic Nameinflatable penile prosthesis
Regulation Number876.3350
PMA NumberP000006
Supplement NumberS012
Date Received10/21/2008
Decision Date12/19/2008
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for three larger cylinder sizes (i. E. , lengths of 24, 26, and 28 cm), and related changes for larger packaging, a modification to the cylinder manufacturing process, additional labels for the larger cylinder sizes, revised instructions for use to include additional catalog numbers for the new cylinder sizes, and a new labeling statement that recommends use of the l00cc reservoir with the new larger cylinder sizes.