- Device
- HeartStart Home Defibrillator and HeartStart Onsite Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S011
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2021-04-19
- Decision code
- OK30
- Date received
- 2021-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the audio production test manufacturing specification performed during the Final Acceptance Test.