PMA P160029S018

Device: M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S018
Product code: NSA
Decision date: 2023-02-16
Classification: Cardiovascular
Generic name: Over-the-counter automated external defibrillator
Approval order statement: Approval for a design change to implement a strip of double sided tape to the leading edge of the hydrogel layer of the HS1 SMART pads.

Current openFDA PMA Record#

Device: M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S018
Product code: NSA
Generic name: Over-the-counter automated external defibrillator
Decision date: 2023-02-16
Decision code: APPR
Date received: 2022-11-18
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a design change to implement a strip of double sided tape to the leading edge of the hydrogel layer of the HS1 SMART pads.