PMA P160029S028

Device: HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S028
Product code: NSA
Decision date: 2025-06-20
Classification: Cardiovascular
Generic name: Over-the-counter automated external defibrillator
Approval order statement: qualification of a new semi-automated piece of machinery to replace the current manual process

Current openFDA PMA Record#

Device: HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S028
Product code: NSA
Generic name: Over-the-counter automated external defibrillator
Decision date: 2025-06-20
Decision code: OK30
Date received: 2025-05-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of a new semi-automated piece of machinery to replace the current manual process