PMA P920032S004

Device
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
Applicant
Pace Medical
PMA number
P920032
Supplement
S004
Product code
JOQ
Decision date
1998-02-27
Generic name
Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Approval order statement
Approval for a modified switch guard design.

Current openFDA PMA Record#

Device
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
Applicant
Pace Medical
PMA number
P920032
Supplement
S004
Product code
JOQ
Generic name
Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Decision date
1998-02-27
Decision code
APPR
Date received
1998-01-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a modified switch guard design.