PMA P160029S017

Device: HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S017
Product code: NSA
Decision date: 2022-07-27
Generic name: Over-the-counter automated external defibrillator
Approval order statement: Replace the current Water Spray System on the Hydrogel Heat Cure Line with a new Water Spray System in order to reduce the variation in the final gel water content.

Current openFDA PMA Record#

Device: HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507
Applicant: Philips Medical Systems, Inc.
PMA number: P160029
Supplement: S017
Product code: NSA
Generic name: Over-the-counter automated external defibrillator
Decision date: 2022-07-27
Decision code: OK30
Date received: 2022-07-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replace the current Water Spray System on the Hydrogel Heat Cure Line with a new Water Spray System in order to reduce the variation in the final gel water content.