IDENTITY SR MODEL 5172 PULSE GENERATOR

FDA premarket approval P910023/S057 · decided 2001-11-27

Approval details

PMA number

P910023

Supplement

S057

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

IDENTITY SR MODEL 5172 PULSE GENERATOR

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2001-10-29

Decision date

2001-11-27

Days to decision

29 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL SR 5172. 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 EXHI

510(k) clearances by this applicant