- Device
- ACTIVITRAX II IPG, ACTIVITRAX IPG, LEGEND II IPG,LEGEND IPG,MICRO MINIX,MINIX,MINIXST IPGS,PREMIER IPG,PREVAIL IPG, VITA
- Applicant
- Medtronic, Inc.
- PMA number
- P850051
- Supplement
- S083
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-06-04
- Decision code
- APPR
- Date received
- 2015-04-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.