PMA P880086S286
- Device
- Assurity, Assurity+, and Endurity
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S286
- Product code
- DXY
- Decision date
- 2017-09-11
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for a change to the capacitance parameter of the Schottky diode.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, and Endurity
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S286
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2017-09-11
- Decision code
- APPR
- Date received
- 2017-07-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the capacitance parameter of the Schottky diode.