PMA P160029S022

Device: HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S022
Product code: NSA
Decision date: 2024-01-23
Classification: Cardiovascular
Generic name: Over-the-counter automated external defibrillator
Approval order statement: qualification of two new impedance test stations that add a supplemental inspection step to the manufacturing process

Current openFDA PMA Record#

Device: HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S022
Product code: NSA
Generic name: Over-the-counter automated external defibrillator
Decision date: 2024-01-23
Decision code: OK30
Date received: 2024-01-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of two new impedance test stations that add a supplemental inspection step to the manufacturing process