- Device
- samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S009
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-04-30
- Decision code
- APPR
- Date received
- 2020-02-03
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes for the SAM350P, SAM360P and SAM 450P public access defibrillators and Pad-Pak accessories.