Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad
FDA premarket approval P010031/S692 · decided 2020-05-08
Approval details
- PMA number
- P010031
- Supplement
- S692
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2020-02-25
- Decision date
- 2020-05-08
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for RAMware updates to ICD, CRT-D, CRT-P, and IPG devices and corresponding updates to Medtronic CareLink Programmer Model 2090 and Encore Programmer Model 29901 device applications SW034, SW035, SW030, and SW040.
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