• 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
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS233
Date Received06/29/2011
Decision Date07/28/2011
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 
Five changes to gen2 hybrid tester final test solution: 1) update to the force measure_ngt2 module; 2) update the pulse amplitude and pulse width test , pulse amplitude 7500 mv and amplitude 7500 mv test sequences; 3) widen the tolerance of the stability check criteria for the pulse amplitude and pulse width test ;4) update the configuration settings for the pulse amplitude 7500 mv and unipolar bipolar switch test and the inter-chamber crosstalk test; and 5) update the electrically erasable programmable read only memory (eeprom) cyclic redundancy check (crc).