LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S015 · decided 2009-12-16
Approval details
- PMA number
- P010030
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2009-10-30
- Decision date
- 2009-12-16
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL OF AN ALTERNATE FLASH/SRAM CHIP FOR USE ON THE WCD 3100, A CORRECTION OF A BILL OF MATERIALS ERROR ON THE WCD 3100 COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, AND TWO DESIGN CHANGES TO THE HIGH VOLTAGE CONVERTER CIRCUIT ON THE DEFIBRILLATOR PRINTED CIRCUIT ASSEMBLY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
| ZOLL ECG Analysis Software (K182093) | Zoll Manufacturing Corporation | 2019-01-28 |
| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |