- Device
- HeartSync Multifunction Disposable Single-Use Defibrillator Pads
- Applicant
- Graphic Controls D.B.A. Vermed
- PMA number
- P200007
- Supplement
- S002
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-12-19
- Decision code
- OK30
- Date received
- 2025-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a modification of the primary packaging pouch for the HeartSync Multifunction Disposable Single-Use AED defibrillator pad, T100AC-Zoll-10, and T100-CS