ADVISA DR MRI A2DR01
FDA premarket approval P980035/S334 · decided 2013-12-06
Approval details
- PMA number
- P980035
- Supplement
- S334
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVISA DR MRI A2DR01
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2013-06-11
- Decision date
- 2013-12-06
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF LABELING CHANGES TO REMOVE THE RESTRICTION STATING THAT THE PATIENT MUST BE POSITIONED WITHIN THE BORE SUCH THAT THE ISOCENTER (CENTER OF THE MRI BORE) IS SUPERIOR TO THE C1 VERTEBRA OR INFERIOR TO THE T12 VERTEBRA AS WELL AS TO REMOVE THE REQUIREMENT THAT MRI SCANS NOT BE PERFORMED ON PATIENTS WITH OTHER PREVIOUSLY IMPLANTED MEDICAL DEVICES.
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