Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Compia MRI, Compia MRI Quad, Consulta, Prot
FDA premarket approval P010031/S684 · decided 2019-12-10
Approval details
- PMA number
- P010031
- Supplement
- S684
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Compia MRI, Compia MRI Quad, Consulta, Prot
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-11-12
- Decision date
- 2019-12-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Expanding the battery manufacturing facility to include additional production floor space with new identical equipment and relocated equipment.
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