BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI
FDA premarket approval P010031/S464 · decided 2014-11-07
Approval details
- PMA number
- P010031
- Supplement
- S464
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-08-27
- Decision date
- 2014-11-07
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.