• 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 Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
PMA NumberP980035
Supplement NumberS308
Date Received02/07/2013
Decision Date03/07/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Multiple manufacturing changes previously accepted for other market released medtronic devices, which included: 1) cmos process flow changes at your supplier; 2) updates to the test software and hardware for integrated circuits; 3) addition of high temperature monitoring to the high power lean line; 4) update to a manufacturing assembly controller system; 5) implementation of a new cleaning process and curing oven; and 6) and implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.