• 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
mounds view, MN 55112
PMA NumberP970012
Supplement NumberS068
Date Received05/17/2010
Decision Date03/22/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
Approval Order Approval Order