LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S071 · decided 2015-12-09
Approval details
- PMA number
- P010030
- Supplement
- S071
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2015-11-23
- Decision date
- 2015-12-09
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- AN ADDITIONAL, PRE-APPROVED SUPPLIER OF A CUSTOM COMPONENT TO BE USED AS PART OF THE DEVICE IN CONSIDERATION.
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510(k) clearances by this applicant
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|---|---|---|
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
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| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |