- Device
- MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
- Applicant
- Pace Medical
- PMA number
- P920032
- Supplement
- S003
- Product code
- JOQ
- Generic name
- Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
- Decision date
- 1996-07-19
- Decision code
- APPR
- Date received
- 1996-01-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- ALTERNATE VENDOR FOR THE CALIBRATED MODULE ASSEMBLY FOR THE MICRO-PACE MODEL 4553, PART NUMBER 02-025-000