• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameMODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS054
Date Received04/03/1998
Decision Date09/24/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic "the analyzer" lead analysis device model 8090 including the model 5436 analyzer patient cable, the models 5103 and 5104 analyzer adaptors, and the model 8190 version 1. 1 software. "the analyzer" is attached to the medtronic model 9790 programmer (approved as p890003/s027) and the model 8190 software is installed onto the hard dirve of this programmer. The device will be marketed under the trade name "medtronic the analyzer(tm) lead analysis device model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting.
-
-