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FDAMarket Authorization
[PMA Approved] Philips HeartStart FR3 Defibrillato — Philips Medical Systems, — P160028
May 11, 2020
Decision Date: 2020-05-11Published: 2020-05-11Captured: 2026-02-20Philips Medical Systems, Inc.Device: Philips HeartStart FR3 DefibrillatorProduct Code: MKJ
FDA approved PMA P160028 (decision: APPR). Philips HeartStart FR3 Defibrillator by Philips Medical Systems, Inc..
- •Trade name: Philips HeartStart FR3 Defibrillator
- •Applicant: Philips Medical Systems, Inc.
- •Decision: APPR
- •Product code: MKJ
Decision:APPR
Device Class:3
Advisory Committee:CV
Statement/Summary
Approval for the Philips HeartStart FR3 Defibrillator. The models 861388 and 861389 are indicated for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudd...
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