• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameTVL(TM) LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defribilation lead system
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Date Received06/30/1995
Decision Date05/10/1996
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 97M-0460
Notice Date 11/19/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the ventritex tvl lead system:transvenous right ventricular lead models rv-1101, rv01, and rv02; transvenous superior vena cava lead models, sv-1101, sv01, sv02, and sv03; subcutaneous lead models, sq-701 and sq01; vein pick model tv-0001; silicone lubricant model tv-0013; lead tunneler kit model ltk-01; model ac-2481 high voltage y-adapter; model ac-cdt-ex ventritex external stimulator adapter; and tvl lead system accessory kit.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 
S057 S058 S060 S061 S062 S063 S064 S067 S068 
S069 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S083 S084 S085 S086 S087 
-
-