Amplia MRI CRT-D, Quad CRT-d; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, Quad CRT-D; Viva
FDA premarket approval P010031/S652 · decided 2018-11-15
Approval details
- PMA number
- P010031
- Supplement
- S652
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI CRT-D, Quad CRT-d; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, Quad CRT-D; Viva
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-10-18
- Decision date
- 2018-11-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Changes to the Polymers Automated Welders software used on the connector components.
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