- Device
- HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S021
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2023-11-15
- Decision code
- OK30
- Date received
- 2023-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the qualification of a new supplier of the High Voltage (HV) Cable connection