Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberP000006
Supplement NumberS012
Date Received10/17/2008
Decision Date12/19/2008
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
-
-