PMA P880086S299
- Device
- Assurity Pacemaker & Endurity Pacemaker
- Applicant
- ABBOTT MEDICAL
- Product code
- DXY
- Decision date
- 2019-10-18
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for an alternate pre-molded header and a sterile barrier inner package tray modification.
Current openFDA PMA Record#
- Device
- Assurity Pacemaker & Endurity Pacemaker
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S299
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2019-10-18
- Decision code
- APPR
- Date received
- 2018-05-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate pre-molded header and a sterile barrier inner package tray modification.