LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S058 · decided 2015-02-22
Approval details
- PMA number
- P010030
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2014-11-13
- Decision date
- 2015-02-22
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR 1) ADDING A NEW SECTION TO THE PATIENT MANUAL THAT ADDRESSES `ENVIRONMENTAL CONSIDERATIONS RELATED TO NOISE AND VIBRATION; 2) ADDING A NEW SECTION TO THE OPERATOR MANUAL THAT ADDRESSES `PHYSICIAN INFORMATION TO INSTRUCT PATIENT CAREGIVERS; AND 3) ADDING A NEW SECTION TO THE PATIENT MANUAL THAT ADDRESSES `WHAT FAMILY MEMBERS NEED TO KNOW.
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| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
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