Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
FDA premarket approval P010031/S728 · decided 2021-04-01
Approval details
- PMA number
- P010031
- Supplement
- S728
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2020-12-09
- Decision date
- 2021-04-01
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the proposed clinical study summary labeling for the Multiple Point Pacing (MPP) Post Approval Clinical Study.
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