Amplia MRI CRT-D & QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D & MRI Quad CRT-D, Viva Quad S & XT CRT-D'
FDA premarket approval P010031/S564 · decided 2016-10-24
Approval details
- PMA number
- P010031
- Supplement
- S564
- 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, Brava Quad CRT-D, Compia MRI CRT-D & MRI Quad CRT-D, Viva Quad S & XT CRT-D'
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-09-27
- Decision date
- 2016-10-24
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Addition of a laser marker removal process to allow for rework on ICD and CRT-D shields.
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