Amplia MRI CRT-D / Amplia MRI Quad CRT-D / Brava CRT-D / Brava Quad CRT-D / Claria MRI & Quad Quad CRT-D / Compia MRI &
FDA premarket approval P010031/S615 · decided 2018-01-03
Approval details
- PMA number
- P010031
- Supplement
- S615
- Supplement type
- 30-Day Notice
- 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 & Quad Quad CRT-D / Compia MRI &
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-12-12
- Decision date
- 2018-01-03
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Addition of manufacturing equipment for use during the interconnect ribbon trim process.
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