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 M
FDA premarket approval P010031/S583 · decided 2017-04-14
Approval details
- PMA number
- P010031
- Supplement
- S583
- 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 M
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-02-09
- Decision date
- 2017-04-14
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for changes to the battery design and corresponding manufacturing changes.
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