• 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 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 Nameprosthesis, testicular
Generic Nameprosthesis, testicular
Regulation Number876.3750
1601 west river road north
minneapolis, MN 55411
PMA NumberP020003
Supplement NumberS006
Date Received11/24/2008
Decision Date12/22/2008
Product Code
FAF[ Registered Establishments with FAF ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of a new method for marking the saline filled testicular prosthesis and the titan inflatable penile prosthesis and for boring suture holes on the titan inflatable penile prosthesis.