GEMINI(R) THETA MODEL 415A CARDIAC PACER
FDA premarket approval P830007/S032 · decided 1990-05-09
Approval details
- PMA number
- P830007
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEMINI(R) THETA MODEL 415A CARDIAC PACER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Telectronics Pacing Systems, Inc.
- Date received
- 1990-04-19
- Decision date
- 1990-05-09
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Englewood, CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MAXIM PF MODELS 033-581/033-590 (K961118) | Telectronics Pacing Systems, Inc. | 1996-07-15 |
| STERILIZATION (K943657) | Telectronics Pacing Systems, Inc. | 1996-06-24 |
| BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (K934899) | Telectronics Pacing Systems, Inc. | 1994-05-12 |
| NEW LEAD INTRODUCER KITS, VARIOUS MODELS (K926340) | Telectronics Pacing Systems, Inc. | 1993-05-27 |
| NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (K914489) | Telectronics Pacing Systems, Inc. | 1992-08-17 |
| UNIVERSAL TERMINAL CAP, 3.2MM (K913919) | Telectronics Pacing Systems, Inc. | 1991-12-31 |
| UNIPOLAR UPSIZING ADAPTOR (K912773) | Telectronics Pacing Systems, Inc. | 1991-10-23 |
| 100 CM PERMANENT PACING LEAD MODELS (K911273) | Telectronics Pacing Systems, Inc. | 1991-08-28 |