HeartSync Multifunction Disposable Single-Use Defibrillator Pads
FDA premarket approval P200007/S002 · decided 2025-12-19
Approval details
- PMA number
- P200007
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartSync Multifunction Disposable Single-Use Defibrillator Pads
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Graphic Controls D.B.A. Vermed
- Date received
- 2025-11-24
- Decision date
- 2025-12-19
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Buffalo, NY
- Statement
- a modification of the primary packaging pouch for the HeartSync Multifunction Disposable Single-Use AED defibrillator pad, T100AC-Zoll-10, and T100-CS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.