CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, MXIMO II M4, PROTECTA CRT-D, PROTECTA M4, XT CRT-D & XT M4
FDA premarket approval P980016/S348 · decided 2012-05-04
Approval details
- PMA number
- P980016
- Supplement
- S348
- Supplement type
- 30-Day Notice
- Trade name
- CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, MXIMO II M4, PROTECTA CRT-D, PROTECTA M4, XT CRT-D & XT M4
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-04-06
- Decision date
- 2012-05-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SOFTWARE UPGRADE TO AN EXISTING TEST EQUIPMENT.
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