PMA P160029S002
- Device
- HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S002
- Product code
- NSA
- Decision date
- 2019-11-26
- Classification
- Over-the-counter Automated External Defibrillator
- Generic name
- Over-the-counter automated external defibrillator
- Approval order statement
- Updates to the assembly process for the HeartStart OnSite and Home Defibrillators.
Current openFDA PMA Record#
- Device
- HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S002
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2019-11-26
- Decision code
- OK30
- Date received
- 2019-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the assembly process for the HeartStart OnSite and Home Defibrillators.