KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.
FDA premarket approval P870054/S014 · decided 1995-07-12
Approval details
- PMA number
- P870054
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Cook Pacemaker Corp.
- Date received
- 1995-06-08
- Decision date
- 1995-07-12
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Leechburg, PA
- Statement
- APPROVAL FOR A CHANGE IN THE ACCELERATED BURN-IN PROCEDURE ON THE LITHIUM/IODINE POWER SOURCE (BATTERY) BY THE VENDOR
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LOCKING STYLET 2 (K970690) | Cook Pacemaker Corp. | 1997-05-20 |
| NEEDLE'S EYE SNARE (K961992) | Cook Pacemaker Corp. | 1996-12-27 |
| MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417) | Cook Pacemaker Corp. | 1995-09-29 |
| MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (K915188) | Cook Pacemaker Corp. | 1992-09-11 |
| MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (K905403) | Cook Pacemaker Corp. | 1991-10-16 |
| MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) (K863582) | Cook Pacemaker Corp. | 1986-10-08 |
| SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS (K861559) | Cook Pacemaker Corp. | 1986-05-09 |
| MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. (K860466) | Cook Pacemaker Corp. | 1986-02-24 |