PMA P160008S017

Device: samaritan 350P (SAM350P) Automated External Defibrillator
Applicant: Heartsine Technologies, Ltd.
Product code: NSA
Decision date: 2022-06-23
Generic name: Over-the-counter automated external defibrillator
Approval order statement: Approval for change to the Indications for Use (IFU) from prescription to Over-the-Counter (OTC) use with associated labeling changes.

Current openFDA PMA Record#

Device: samaritan 350P (SAM350P) Automated External Defibrillator
Applicant: Heartsine Technologies, Ltd.
PMA number: P160008
Supplement: S017
Product code: NSA
Generic name: Over-the-counter automated external defibrillator
Decision date: 2022-06-23
Decision code: APPR
Date received: 2022-03-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for change to the Indications for Use (IFU) from prescription to Over-the-Counter (OTC) use with associated labeling changes.