• 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 NameTRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemakers
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP900070
Supplement NumberS026
Date Received01/31/2000
Decision Date02/18/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.
-
-