MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
FDA premarket approval P920032/S003 · decided 1996-07-19
Approval details
- PMA number
- P920032
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
- Generic name
- Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
- Applicant
- Pace Medical
- Date received
- 1996-01-19
- Decision date
- 1996-07-19
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- JOQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- ALTERNATE VENDOR FOR THE CALIBRATED MODULE ASSEMBLY FOR THE MICRO-PACE MODEL 4553, PART NUMBER 02-025-000
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (K011980) | Pace Medical | 2001-09-12 |
| DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (K012392) | Pace Medical | 2001-09-04 |
| PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (K002204) | Pace Medical | 2000-10-18 |
| MODEL 4810 ANALYZER OUTPUT ADAPTER (K002497) | Pace Medical | 2000-10-10 |
| MODEL 4815 ADAPTER (K002496) | Pace Medical | 2000-10-10 |
| TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 (K001180) | Pace Medical | 2000-06-27 |
| MODEL 4800 ACCUPACE PACING SYSTEM ANALYER (K925143) | Pace Medical | 1994-09-27 |
| LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES (K931662) | Pace Medical | 1993-08-31 |