- Device
- HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A)
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S024
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2024-02-21
- Decision code
- APPR
- Date received
- 2024-01-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a battery manufacturing site located at Panasonic Energy Mexico, S.A. de C.V., Escobedo N.L., Mexico