IDENTITY XL DR MODEL 5376 PULSE GENERATOR

FDA premarket approval P880086/S086 · decided 2001-11-27

Approval details

PMA number

P880086

Supplement

S086

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

IDENTITY XL DR MODEL 5376 PULSE GENERATOR

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2001-10-29

Decision date

2001-11-27

Days to decision

29 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL XL DR 5376. THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS. RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY. DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS E

510(k) clearances by this applicant