- Device
- COSMOS/NOVA/QUANTUM/SUPRIMA/PULSE GENERATORS
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S067
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-08-19
- Decision code
- APPR
- Date received
- 1996-03-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS