HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
FDA premarket approval P200007/S001 · decided 2025-11-12
Approval details
- PMA number
- P200007
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2025-04-18
- Decision date
- 2025-11-12
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Buffalo, NY
- Statement
- approval for an update to a manufacturing step of an intermediate component of the radiotransparent defibrillator pads
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