Zoll AED 3 and Zoll AED 3 Automatic
FDA premarket approval P160015/S005 · decided 2021-06-28
Approval details
- PMA number
- P160015
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zoll AED 3 and Zoll AED 3 Automatic
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2020-07-30
- Decision date
- 2021-06-28
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for changes made to Zoll AED 3 and ZOLL AED 3 Automatic device including software update (Release 6), minor hardware changes, and introducing ZOLL AED 3 Aviation and ZOLL AED 3 Aviation Battery Pack.
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