WEARABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P010030/S038 · decided 2012-11-20
Approval details
- PMA number
- P010030
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WEARABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2012-10-22
- Decision date
- 2012-11-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- MODIFICATIONS TO A FIXTURE AND A CHANGE IN THE BACKUP BATTERY CHARGING PROCESS DURING THE THERMAL CYCLING.
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| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
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