CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS
FDA premarket approval P010031/S147 · decided 2009-05-21
Approval details
- PMA number
- P010031
- Supplement
- S147
- Supplement type
- Normal 180 Day Track
- Trade name
- CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-03-02
- Decision date
- 2009-05-21
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
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