PMA P940031S015
- Device
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S015
- Product code
- LWP
- Decision date
- 1998-07-24
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for a modification to the specification of the "runaway" rate for the above referenced families of pacemakers from 220+10% to 205+5%.
Current openFDA PMA Record#
- Device
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S015
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1998-07-24
- Decision code
- APPR
- Date received
- 1998-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the specification of the "runaway" rate for the above referenced families of pacemakers from 220+10% to 205+5%.