- Device
- HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HS1 SMART Pads, Adult, HS1 SMART Pads, Infant/Child
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S013
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2021-08-10
- Decision code
- OK30
- Date received
- 2021-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the mixing process for hydrogel pads.