HeartStart FRx Defibrillator
FDA premarket approval P180028/S002 · decided 2020-08-03
Approval details
- PMA number
- P180028
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartStart FRx Defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Philips Medical Systems
- Date received
- 2020-07-06
- Decision date
- 2020-08-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Changes to the inspection procedure for components and sub-assemblies used to build the HeartStart family of defibrillators.
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