HeartStart FRx Defibrillator
FDA premarket approval P180028/S006 · decided 2021-02-12
Approval details
- PMA number
- P180028
- Supplement
- S006
- 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
- 2021-01-21
- Decision date
- 2021-02-12
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Inspection procedure changes for components and sub-assemblies used in the manufacture of the HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A) and HeartStart FRx Defibrillator (Model 861304).
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