HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
FDA premarket approval P200007 · decided 2023-06-23
Approval details
- PMA number
- P200007
- Trade name
- HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Graphic Controls D.B.A. Vermed
- Date received
- 2020-02-03
- Decision date
- 2023-06-23
- Days to decision
- 1236 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Buffalo, NY
- Statement
- Approval for the HeartSync Multifunctional Defibrillation Electrodes. These devices are indicated for:For Automatic External Defibrillators: (Compatible Model AEDs: Physio Control: LifePak-15, LifePak-20/20e, LifePak -1000; Zoll Medical: R-Series, X-Series; Cardiac Science: PowerHeart AED G3 Plus, PowerHeart AED G3 Pro).When used with an external defibrillator, these electrode pads are for treating patients in cardiopulmonary arrest who are: 1) Unconscious; 2) Not breathing spontaneously; and 3)
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