LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S040 · decided 2013-06-25
Approval details
- PMA number
- P010030
- Supplement
- S040
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2013-02-05
- Decision date
- 2013-06-25
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER OF AN ELECTRODE COMPONENT USED IN THE DEVICE.
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