PMA P160008S003
- Device
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S003
- Product code
- MKJ
- Decision date
- 2018-12-17
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Implement minor manufacturing process improvements at the battery supplier.
Current openFDA PMA Record#
- Device
- HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S003
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-12-17
- Decision code
- OK30
- Date received
- 2018-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement minor manufacturing process improvements at the battery supplier.