• 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 NameMEDTRONIC SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacer cardioverter defibrillator
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS016
Date Received08/12/1999
Decision Date09/24/1999
Product Code
LWS
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a caution label to the medtronic(r) sprint(tm) lead models 6932, 6937, 6942, 6943 and 6945.
-
-