PMA P880086S287
- Device
- Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S287
- Product code
- DXY
- Decision date
- 2017-09-11
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Change in the header manufacturing process.
Current openFDA PMA Record#
- Device
- Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S287
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2017-09-11
- Decision code
- OK30
- Date received
- 2017-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the header manufacturing process.