PMA P850051S082
- Device
- Activitrax Ii Ipg,activitrax Ipg,legend Ii Ipg,legend Ipg,mi
- Applicant
- MEDTRONIC Inc.
- PMA number
- P850051
- Supplement
- S082
- Decision date
- 2015-10-19
Current openFDA PMA Record
- Device
- ACTIVITRAX II IPG,ACTIVITRAX IPG,LEGEND II IPG,LEGEND IPG,MICRO MINIX IPG,MINIX IPG,MINIX ST IPG,PREMIER IPG,PREVAIL IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P850051
- Supplement
- S082
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-10-19
- Decision code
- APPR
- Date received
- 2014-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.