• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTITAN INFLATABLE PENILE PROSTHESIS
Classification Namedevice, impotence, mechanical/hydraulic
Generic Nameinflatable penile prosthesis
Regulation Number876.3350
ApplicantCOLOPLAST CORP.
PMA NumberP000006
Date Received01/18/2000
Decision Date07/14/2000
Product Code
FHW[ Registered Establishments with FHW ]
Docket Number 00M-1415
Notice Date 07/25/2000
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the mentor alpha i inflatable penile prosthesis. This device is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 S009 S010 S011 
S012 S013 S014 S015 S017 S018 S019 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S031 
S032 S033 S035 
-
-