LIFEVEST WCD 3000
FDA premarket approval P010030/S008 · decided 2007-10-31
Approval details
- PMA number
- P010030
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WCD 3000
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2006-08-11
- Decision date
- 2007-10-31
- Days to decision
- 446 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR A CHANGE IN THE BATTERY PACK PCA ARTWORK, ADDITION OF 100-OHM RESISTOR AT U3 PIN 1, AND A CHANGE OF THE DOUBLE-SIDED PRESSURE SENSITIVE ADHESIVE (PSA) TAPE.
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