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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.
 
DeviceTITAN 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 NumberS012
Date Received10/17/2008
Decision Date12/19/2008
Product Code
FHW[ Registered Establishments with FHW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THREE LARGER CYLINDER SIZES (I.E., LENGTHS OF 24, 26, AND28 CM), AND RELATED CHANGES FOR LARGER PACKAGING, A MODIFICATION TO THE CYLINDER MANUFACTURINGPROCESS, 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.
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