LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S066 · decided 2015-10-02
Approval details
- PMA number
- P010030
- Supplement
- S066
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2015-09-03
- Decision date
- 2015-10-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- ALTERNATE SUPPLIER, SUN STAR, INC., IN LATROBE, PENNSYLVANIA FOR THE ECG BACKCOVER WITH RETAINER DUAL AND ECG BACK COVER WITH RETAINER SINGLE.
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