CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,MAXIMO II CRT-D,MAXIMO II DF4 CRT-D,PROTECTA CRT-D,PROTECTA DF4 CRT-D
FDA premarket approval P010031/S336 · decided 2012-11-02
Approval details
- PMA number
- P010031
- Supplement
- S336
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,MAXIMO II CRT-D,MAXIMO II DF4 CRT-D,PROTECTA CRT-D,PROTECTA DF4 CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-09-27
- Decision date
- 2012-11-02
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE RAW MATERIAL OF THE CAPACITORS USED IN THE HIGH VOLTAGE DELIVERY CIRCUITRY.
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