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 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.
 
DevicePROGRAMMER TO SUPPORT VARIOUS PACEMAKERS & DEFIBRILLATORS
Generic NamePulse generator, permanent, implantable
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP830045
Supplement NumberS092
Date Received11/14/2005
Decision Date02/08/2006
Withdrawal Date 06/20/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO.
-
-