PMA P010031S511
- Device
- BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S511
- Product code
- KRG
- Decision date
- 2015-10-29
- Classification
- Programmer, Pacemaker
- Generic name
- Programmer, pacemaker
- Approval order statement
- APPROVAL FOR THREE NEW ALTERNATE INTEGRATED CIRCUITS TO BE USED IN THE DEVICES.
Current openFDA PMA Record#
- Device
- BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S511
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 2015-10-29
- Decision code
- APPR
- Date received
- 2015-09-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THREE NEW ALTERNATE INTEGRATED CIRCUITS TO BE USED IN THE DEVICES.