PMA P830045S051

Device: PHOENIX 2 AND PARAGON II PACING SYSTEMS
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S051
Product code: LWP
Decision date: 1996-10-09
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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

Current openFDA PMA Record

Device: PHOENIX 2 AND PARAGON II PACING SYSTEMS
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S051
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1996-10-09
Decision code: APPR
Date received: 1996-03-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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