IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

FDA premarket approval P910023/S066 · decided 2003-03-20

Approval details

PMA number

P910023

Supplement

S066

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2003-03-03

Decision date

2003-03-20

Days to decision

17 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A. THESE DEVICES ARE INDICATED AS FOLLOWS: IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS. DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYN

510(k) clearances by this applicant