LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S034 · decided 2012-07-25
Approval details
- PMA number
- P010030
- Supplement
- S034
- 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
- 2012-05-29
- Decision date
- 2012-07-25
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR A CHANGE OF PLATING MATERIAL FROM TIN TO GOLD ON THE FOLLOWING COMPONENTS: 1) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER BOARD AND HIGH VOLTAGE BOARD; 2) 12-POSITION JUMPER; AND 3) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER, BEDSIDE, AND BATTERY CONNECTOR BOARDS.
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 |