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IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
BOSTONSCIENTIFIC
Trade Name
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
4/25/2016
Days to Decision
419 days
Decision Code
APPR
FDA Decision
Approval

IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
BOSTONSCIENTIFIC
Trade Name
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
4/25/2016
Days to Decision
419 days
Decision Code
APPR
FDA Decision
Approval