PMA P160029S026
- Device
- HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S026
- Product code
- NSA
- Decision date
- 2024-12-12
- Classification
- Cardiovascular
- Generic name
- Over-the-counter automated external defibrillator
- Approval order statement
- material change to pads
Current openFDA PMA Record#
- Device
- HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S026
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2024-12-12
- Decision code
- APPR
- Date received
- 2024-09-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- material change to pads