AED 3 Defibrillator with Uni-Padz
FDA premarket approval P160015/S004 · decided 2020-06-05
Approval details
- PMA number
- P160015
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AED 3 Defibrillator with Uni-Padz
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2020-03-27
- Decision date
- 2020-06-05
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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510(k) clearances by this applicant
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| ZOLL X Series (K142915) | ZOLL Medical Corporation | 2014-12-03 |
| ZOLL X SERIES (K141774) | ZOLL Medical Corporation | 2014-11-19 |