- Device
- HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S029
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2026-02-02
- Decision code
- OK30
- Date received
- 2026-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update from the current manual manufacturing method to a semi-automated manufacturing method