• 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.
 
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 NumberS201
Date Received02/10/2009
Decision Date04/08/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CURRENT/CURRENT+ AND PROMOTE/PROMOTE+ DEVICES INCLUDING CURRENT- DR CD2211-36Q, CURRENT+ VR CD1211-36Q, PROMOTE + CD3211-36Q, CURRENT VR CD1207-36Q, CURRENT DR 2207-36Q, AND PROMOTE CD3207-36Q. ADDITIONALLY, YOUREQUESTED APPROVAL TO INCLUDE THE DEVICES WITHIN AN ONGOING POST APPROVAL STUDY, PENDING FINAL APPROVAL BY THE OFFICE OF SURVEILLANCE AND BIOMETRICS. THAT POST-APPROVAL STUDY IS BEING CONDUCTED AS A CONDITION OF APPROVAL FOR P950022/S042, P030054/S067, AND P910023/S154.
-
-