• 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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910020
Supplement NumberS017
Date Received08/05/1996
Decision Date02/10/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the marathon dr and sr pulse generators, graphics program module model 570-01, and to the release 2. 00 software for use with the rx5000 graphics programmer. The device, as modified, will be marketed under the trade names marathon z pulse generator maodels 294-09z and 292-09z, momentum dr pulse generator models 294-23, 294-23z, and 292-23, graphics program module model 570-01, and release 2. 02 software with use with rx5000 graphics programmer, and is indicated for long term cardiac pacing.