WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000.
FDA premarket approval P010030/S086 · decided 2017-04-25
Approval details
- PMA number
- P010030
- Supplement
- S086
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000.
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2016-10-27
- Decision date
- 2017-04-25
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval to modify the Zoll Wearable Cardioverter Defibrillator (WCD) 3000, 3100, and 4000 Operators Manuals to reflect the results of the Post-Approval Study.
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