- Device
- HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S012
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2021-06-15
- Decision code
- OK30
- Date received
- 2021-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New battery end of line test equipment for the HS1 and FRx Primary Battery, and the FRx Aviation Battery at the contract manufacturer.