- Device
- HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S006
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2020-08-22
- Decision code
- OK30
- Date received
- 2020-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the inspection procedures for components and subassemblies used to build the HeartStart family of defibrillators.