PMA P010031S478
- Device
- BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S478
- Product code
- OSR
- Decision date
- 2015-10-19
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
Current openFDA PMA Record#
- Device
- BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S478
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- 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.