• 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.
 
DeviceCADENCE FAMILY OF ICDS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS176
Date Received05/21/2008
Decision Date06/09/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
-
-