Advisa MRI DR & SR Surescan Implantable Pulse Generators Models A2DR01 & A3SR01
FDA premarket approval P980035/S464 · decided 2016-09-07
Approval details
- PMA number
- P980035
- Supplement
- S464
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Advisa MRI DR & SR Surescan Implantable Pulse Generators Models A2DR01 & A3SR01
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-03-11
- Decision date
- 2016-09-07
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
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