AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, CLARIA MRI CRT-D, CLARIA MRI QUAD CRT-D, COMPIA
FDA premarket approval P010031/S570 · decided 2017-02-02
Approval details
- PMA number
- P010031
- Supplement
- S570
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, CLARIA MRI CRT-D, CLARIA MRI QUAD CRT-D, COMPIA
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-10
- Decision date
- 2017-02-02
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a minor design change and associated manufacturing changes to the Medtronic Advanced Valve Metal (AVM) Capacitor Feedthrough.
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