Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro
FDA premarket approval P010031/S590 · decided 2017-04-23
Approval details
- PMA number
- P010031
- Supplement
- S590
- 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/Compai MRI Quad/Consulta/Maximo II/Pro
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-04-03
- Decision date
- 2017-04-23
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Addition a rework process at a supplier for the barrels used in Multi Beam Contacts.
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