PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)

FDA premarket approval P910023/S053 · decided 2001-07-18

Approval details

PMA number

P910023

Supplement

S053

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2001-06-28

Decision date

2001-07-18

Days to decision

20 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE USE OF A NEW BATTERY MODEL (WGL 2150) FOR THE LEGALLY MARKETED ST. JUDE MEPRO MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) AND P 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232). IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL FOR THE USE OF AN ALTERNATE IS-1 RECEPTACLE PLUG, MODEL AC-IP-2, FOR TH 5 DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND AR

510(k) clearances by this applicant