• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameMEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS050
Date Received05/05/1997
Decision Date06/03/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: medtronic models 5038-58, 5038-65, 5038-52, 5038s-58, and 5038l-65 capsure vdd-2 and vitatron models imw 14q/15q/16q/17q/18q brilliant s+ vdd pacing leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current medtronic(r) vdd pacemakers.
-
-