PMA P160029S009

Device: HeartStart Home Defibrillator and HeartStart OnSite Defibrillator
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S009
Product code: NSA
Decision date: 2021-02-12
Generic name: Over-the-counter automated external defibrillator
Approval order statement: Inspection procedure changes for components and sub-assemblies used in the manufacture of the HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A) and HeartStart FRx Defibrillator (Model 861304).

Current openFDA PMA Record#

Device: HeartStart Home Defibrillator and HeartStart OnSite Defibrillator
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S009
Product code: NSA
Generic name: Over-the-counter automated external defibrillator
Decision date: 2021-02-12
Decision code: OK30
Date received: 2021-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Inspection procedure changes for components and sub-assemblies used in the manufacture of the HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A) and HeartStart FRx Defibrillator (Model 861304).