TELECTRONICS PASAR MODEL 4171 PG
FDA premarket approval P850027/S003 · decided 1990-03-22
Approval details
- PMA number
- P850027
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELECTRONICS PASAR MODEL 4171 PG
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Applicant
- Telectronics, Inc.
- Date received
- 1989-11-02
- Decision date
- 1990-03-22
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- LWW
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Englewood, CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IMPLANTABLE ADAPTOR 033-380 (K890895) | Telectronics, Inc. | 1990-03-06 |
| OPTIMA MPT AND SPT PACEMAKERS (K891231) | Telectronics, Inc. | 1989-09-12 |
| VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (K890350) | Telectronics, Inc. | 1989-02-02 |
| OPTIMA MPT AND SPT PACEMAKERS (K884411) | Telectronics, Inc. | 1989-01-26 |
| IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (K884278) | Telectronics, Inc. | 1988-12-15 |
| OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (K881837) | Telectronics, Inc. | 1988-07-18 |
| IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (K874664) | Telectronics, Inc. | 1988-05-31 |
| MODEL 1740 PERSONAL POCKET PROGRAMMER (K864712) | Telectronics, Inc. | 1987-12-17 |