PMA P880086S310
- Device
- Endurity, Assurity, and Accent
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S310
- Product code
- DXY
- Decision date
- 2020-01-06
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Implement two new inspection processes.
Current openFDA PMA Record#
- Device
- Endurity, Assurity, and Accent
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S310
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-01-06
- Decision code
- OK30
- Date received
- 2019-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement two new inspection processes.