Medtronic Revo MRI SureScan IPG and Pacing System
FDA premarket approval P980035/S587 · decided 2019-05-30
Approval details
- PMA number
- P980035
- Supplement
- S587
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Medtronic Revo MRI SureScan IPG and Pacing System
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-04-05
- Decision date
- 2019-05-30
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for labeling updates.
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