HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R

FDA premarket approval P910023/S071 · decided 2003-11-06

Approval details

PMA number

P910023

Supplement

S071

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R

Generic name

implantable pacemaker Pulse-generator

Applicant

ABBOTT MEDICAL

Date received

2003-10-07

Decision date

2003-11-06

Days to decision

30 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR MODIFICATIONS TO THE HOUSECALL 2.0 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM AND IS INDICATED AS FOLLOWS: THE HOUSECALL PLUS SYSTEM IS INDICATED FOR USE IN PERFORMING REMOTE FOLLOW-UP MONITORING ON PATIENTS HAVING THE FOLLOWING ST. JUDE MEDICAL CARDIOVERTER/ DEFRIBRILLATORS: ATLAS DR MODEL V-240, ATLAS VR MODEL V-199, EPIC+ DR MODEL V-236, EPIC+ VR MODEL V-1961, EPIC DR MODEL V-235 AND EPIC VR MODEL V-197.

510(k) clearances by this applicant