MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO 2 CRT-D D284TRK, CONCERTO 2 D274TRK IMPLANTSBLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P010031/S193 · decided 2010-05-11
Approval details
- PMA number
- P010031
- Supplement
- S193
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO 2 CRT-D D284TRK, CONCERTO 2 D274TRK IMPLANTSBLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-03-31
- Decision date
- 2010-05-11
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS.
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