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.
 
DeviceKELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantCOOK PACEMAKER CORP.
ROUTE 66 RIVER RD.
P.O. BOX 529
LEECHBURG, PA 15656
PMA NumberP870054
Supplement NumberS014
Date Received06/08/1995
Decision Date07/12/1995
Withdrawal Date 12/01/2004
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE ACCELERATED BURN-IN PROCEDURE ON THE LITHIUM/IODINE POWER SOURCE (BATTERY) BY THE VENDOR
-
-