• 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
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS068
Date Received01/26/2009
Decision Date05/12/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00336284
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existingprecautions and the following marketing statements:1) biotronic home monitoring information may be used as a replacement fordevice interrogation during in-office follow-up visits. 2) a strategy of care using biotronik home monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-officefollow-ups of biotronik implantable devices in many patients. Home monitoring data is helpful in determining the need for additional in-office follow-up. 3) biotronik home monitoring patients -who are followed remotely with officevisits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) biotronik home monitoring provides early detection of arrhythmias. 5) biotronik home monitoring provides early detection of silent, asymptomatic arrhythmias. 6) automatic early detection of arrhythmias and device system anomalies bybiotronik home monitoring allows for earlier intervention than conventional in-officefollow-ups. 7) biotronik home monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automaticallyscheduled at regular intervals.