Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG
FDA premarket approval P980035/S721 · decided 2022-08-26
Approval details
- PMA number
- P980035
- Supplement
- S721
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2022-06-17
- Decision date
- 2022-08-26
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for addition of the summary for your Post Approval Study, Pacing Capture Threshold (PCT) Change Following 3T MRI Scan of MR Conditional CIEDs, to the labeling.
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