Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs)
FDA premarket approval P980035/S481 · decided 2017-04-25
Approval details
- PMA number
- P980035
- Supplement
- S481
- 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 (IPGs)
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-11-02
- Decision date
- 2017-04-25
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.
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