ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS

FDA premarket approval P960030/S012 · decided 2005-04-27

Approval details

PMA number

P960030

Supplement

S012

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS

Generic name

permanent pacemaker Electrode

Applicant

ABBOTT MEDICAL

Date received

2004-08-03

Decision date

2005-04-27

Days to decision

267 days

Decision code

APPR

Product code

DTB

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ADDITION OF A POLYURETHANE INSULATOR. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ISOFLEX P 1644T AND ISOFLEX P 1648T LEADS AND ARE INDICATED FOR USE IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM (MODEL 1644T) OR VENTRICLE (MODEL 1648T).

510(k) clearances by this applicant