- Device
- HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
- Applicant
- Graphic Controls D.B.A. Vermed
- PMA number
- P200007
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-11-12
- Decision code
- APPR
- Date received
- 2025-04-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an update to a manufacturing step of an intermediate component of the radiotransparent defibrillator pads