POLY-SAFE(TM) A-TRACK(TM) PACING LEADS
FDA premarket approval P890039/S016 · decided 1998-11-09
Approval details
- PMA number
- P890039
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- POLY-SAFE(TM) A-TRACK(TM) PACING LEADS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Cardiac Control Systems, Inc.
- Date received
- 1996-07-19
- Decision date
- 1998-11-09
- Days to decision
- 843 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Palm Coast, FL
- Statement
- Approval for the use of BioSpan(R) (MS/0.4 as a raw material for the polyurethane insulation for the above lead models.
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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 |