PMA P880086S300
- Device
- Assurity, Assurity +, Endurity, Accent and Victory XL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S300
- Product code
- DXY
- Decision date
- 2018-06-15
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Implementation of an automated environment monitoring system.
Current openFDA PMA Record#
- Device
- Assurity, Assurity +, Endurity, Accent and Victory XL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S300
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-06-15
- Decision code
- OK30
- Date received
- 2018-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated environment monitoring system.