SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS

FDA premarket approval P880086/S035 · decided 1996-10-09

Approval details

PMA number

P880086

Supplement

S035

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

1996-03-12

Decision date

1996-10-09

Days to decision

211 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

MODIFICATION TO THE 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 PRECAUTIONS NEED TO BE TAKEN BY PATIENTS RECEIVING T

510(k) clearances by this applicant