PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4
FDA premarket approval P010031/S304 · decided 2012-06-29
Approval details
- PMA number
- P010031
- Supplement
- S304
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-05-01
- Decision date
- 2012-06-29
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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