- Device
- HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S016
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2022-06-08
- Decision code
- OK30
- Date received
- 2022-05-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate Heat Sealer used in the current electrode final assembly.