MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM
FDA premarket approval P860027/S010 · decided 1995-09-26
Approval details
- PMA number
- P860027
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Cardiac Control Systems, Inc.
- Date received
- 1995-03-01
- Decision date
- 1995-09-26
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palm Coast, FL
- Statement
- APPROVAL FOR THE MAWSTRO II MODEL 533 PACEMAKER SYSTEM
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 (K971775) | Cardiac Control Systems, Inc. | 1997-12-29 |
| CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188) | Cardiac Control Systems, Inc. | 1995-05-15 |
| CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210) | Cardiac Control Systems, Inc. | 1995-05-03 |
| CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER (K923868) | Cardiac Control Systems, Inc. | 1993-05-14 |
| MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE (K905824) | Cardiac Control Systems, Inc. | 1991-05-16 |
| MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE (K904941) | Cardiac Control Systems, Inc. | 1991-01-03 |
| MAESTRO PACEMAKER TEST MAGNET (K895110) | Cardiac Control Systems, Inc. | 1989-09-26 |
| MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER (K884023) | Cardiac Control Systems, Inc. | 1988-10-17 |