- Device
- HeartStart Home Defibrillator and HeartStart Onsite Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S005
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2020-08-03
- Decision code
- OK30
- Date received
- 2020-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the inspection procedure for components and sub-assemblies used to build the HeartStart family of defibrillators.