AED 3 defibrillator
FDA premarket approval P160015/S001 · decided 2020-02-28
Approval details
- PMA number
- P160015
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AED 3 defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2017-08-18
- Decision date
- 2020-02-28
- Days to decision
- 924 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for the AED 3 Defibrillator.
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