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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTITAN INFLATABLE PENILE PROSTHESIS
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP000006
Date Received01/18/2000
Decision Date07/14/2000
Product Code FHW 
Docket Number 00M-1415
Notice Date 07/25/2000
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S033 S026 S027 S040 S041 S042 S043 S035 S045 S037 S001 
S002 S003 S005 S014 S004 S011 S010 S007 S046 S025 S023 S024 
S028 S029 S030 S031 S032 S044 S036 S034 S038 S039 S022 S009 
S015 S012 S013 S019 S021 S017 S018 S047 S063 S067 S049 S051 
S056 S053 S054 S057 S058 S050 S052 S061 S064 S065 S066 S060 
S062 S059 S069 S068 S070 S071 
-
-