LIFEVEST WEARABLE DEBRILLATOR
FDA premarket approval P010030/S039 · decided 2012-12-20
Approval details
- PMA number
- P010030
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2012-11-21
- Decision date
- 2012-12-20
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR:1) DESIGN MODIFICATIONS TO THE MONITOR ENCLOSURE; 2) ADDITION OF EP11HT GRAY EPOXY TO THE HIGH VOLTAGE CAPACITOR SOLDER JOINTS; AND3) ADDITION OF LOCTITE 3536 EPOXY UNDERFILL TO THE BALL GRID ARRAY COMPONENTS OF THE PRINTED CIRCUIT ASSEMBLIES
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 |