PMA P970012S093
- Device
- KAPPA 400
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S093
- Product code
- LWP
- Decision date
- 2013-06-11
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- KAPPA 400
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S093
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-06-11
- Decision code
- APPR
- Date received
- 2013-04-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.