• 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.
 
DeviceINTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL
Classification Nameprogrammer, pacemaker
Generic Nameprogrammer, pacemaker
Regulation Number870.3700
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP830045
Supplement NumberS072
Date Received09/22/2000
Decision Date10/02/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.
-
-