INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM
FDA premarket approval P010031/S397 · decided 2014-02-14
Approval details
- PMA number
- P010031
- Supplement
- S397
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-08-23
- Decision date
- 2014-02-14
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
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