Medtronic Attesta and Sphera MRI SureScan IPG and Pacing System
FDA premarket approval P980035/S637 · decided 2020-10-08
Approval details
- PMA number
- P980035
- Supplement
- S637
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Medtronic Attesta and Sphera MRI SureScan IPG and Pacing System
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2020-08-12
- Decision date
- 2020-10-08
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for labeling updates for the Attesta and Sphera MRI SureScan Systems.
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