PMA P010030S071
- Device
- LIFEVEST WEARABLE DEFIBRILLATOR
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S071
- Product code
- MVK
- Decision date
- 2015-12-09
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- AN ADDITIONAL, PRE-APPROVED SUPPLIER OF A CUSTOM COMPONENT TO BE USED AS PART OF THE DEVICE IN CONSIDERATION.
Current openFDA PMA Record#
- Device
- LIFEVEST WEARABLE DEFIBRILLATOR
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S071
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2015-12-09
- Decision code
- OK30
- Date received
- 2015-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN ADDITIONAL, PRE-APPROVED SUPPLIER OF A CUSTOM COMPONENT TO BE USED AS PART OF THE DEVICE IN CONSIDERATION.