- Device
- HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S014
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2022-05-09
- Decision code
- APPR
- Date received
- 2021-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in formula for the hydrogel used on the M5071A and M5072A Adult and Infant/Child SMART Pads.