INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

FDA premarket approval P880086/S083 · decided 2001-07-11

Approval details

PMA number

P880086

Supplement

S083

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2001-03-08

Decision date

2001-07-11

Days to decision

125 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE INTEGRITY AFX DR MODEL 5346 PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: 1)SYNCOPE 2) PRESYNCOPE 3) FATIGUE 4) DISORIENTATION 5) OR ANY COMBINATION OF THOSE SYMPTOMS. RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT

510(k) clearances by this applicant