Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePHOENIX 2 AND PARAGON II PACING SYSTEMS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP830045
Supplement NumberS051
Date Received03/12/1996
Decision Date10/09/1996
Withdrawal Date 06/20/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATION OF LABELING TO INCLUDE A "CELLULAR TESTED" LOGO TO THE SHELF PACKAGE OF THE FOLLOWING PACEMAKER MODELS: PHOENIX 2 (2005/2008/2009), PARAGON (2010/2011/2012), PARAGON II (2016), SYNCHRONY (2020), SYNCHRONY II (2022/2023), SYNCHRONY III (2028/2029), SOLUS (2002/2003), SOLUS II (2006/2007), TRILOGY (2350/2308/2250) AND REVISION OF THE PATIENT MANUAL TO INCLUDE THE LOGO AND LANGUAGE INFORMING THE PATIENT THAT NO SPECIAL CELL PHONE PRECAUSTIONS NEED BE TAKEN BY PATIENTS RECEIVING THESE MODELS
-
-