CRT-D MRI Application Software, Blackwell Application Software
FDA premarket approval P010031/S853 · decided 2024-06-04
Approval details
- PMA number
- P010031
- Supplement
- S853
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CRT-D MRI Application Software, Blackwell Application Software
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-03-12
- Decision date
- 2024-06-04
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for software changes related to the short circuit protection feature
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