CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,CONCERTO CRT-D, PROTECTA AND PROTECTA XT,VIVA XT,VIVA S,BRAVA CRT-DS
FDA premarket approval P010031/S499 · decided 2015-05-04
Approval details
- PMA number
- P010031
- Supplement
- S499
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,CONCERTO CRT-D, PROTECTA AND PROTECTA XT,VIVA XT,VIVA S,BRAVA CRT-DS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-03-06
- Decision date
- 2015-05-04
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
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