PMA P160008S035
- Device
- HeartSine® samaritan® (SAM) Public Access Defibrillator (PAD) SAM 350P, SAM 360P and SAM 450P and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S035
- Product code
- MKJ
- Decision date
- 2026-06-22
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- a battery supplier manufacturing site change
Current openFDA PMA Record#
- Device
- HeartSine® samaritan® (SAM) Public Access Defibrillator (PAD) SAM 350P, SAM 360P and SAM 450P and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S035
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-06-22
- Decision code
- OK30
- Date received
- 2026-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a battery supplier manufacturing site change