PMA P880086S296
- Device
- Assurity, Endurity
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S296
- Product code
- DXY
- Decision date
- 2018-03-05
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Alternate supplier for connector block components.
Current openFDA PMA Record#
- Device
- Assurity, Endurity
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S296
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-03-05
- Decision code
- OK30
- Date received
- 2018-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for connector block components.