- Device
- KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.
- Applicant
- Cook Pacemaker Corp.
- PMA number
- P870054
- Supplement
- S014
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1995-07-12
- Decision code
- APPR
- Date received
- 1995-06-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE ACCELERATED BURN-IN PROCEDURE ON THE LITHIUM/IODINE POWER SOURCE (BATTERY) BY THE VENDOR