CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
FDA premarket approval P010031/S232 · decided 2012-04-04
Approval details
- PMA number
- P010031
- Supplement
- S232
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-01-24
- Decision date
- 2012-04-04
- Days to decision
- 436 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE AS FOLLOWS.FOR THE CONCERTO CRT-D MODEL C154DWK, CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, PROTECTA CRT-D MODEL D334TRG, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA XT CRT-D MODEL D314TRM, AND CONSULTA CRT-D MODEL D204TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: THE CRT-D SYSTEM IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DE
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