PMA P980035S334

Device: ADVISA DR MRI A2DR01
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S334
Product code: NVZ
Decision date: 2013-12-06
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order 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.

Current openFDA PMA Record#

Device: ADVISA DR MRI A2DR01
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S334
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2013-12-06
Decision code: APPR
Date received: 2013-06-11
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.