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HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
Trade Name
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Generic Name
Over-the-counter automated external defibrillator
Decision Date
6/6/2019
Days to Decision
1042 days
Decision Code
APPR
FDA Decision
Approval

HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
Trade Name
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Generic Name
Over-the-counter automated external defibrillator
Decision Date
6/6/2019
Days to Decision
1042 days
Decision Code
APPR
FDA Decision
Approval