PMA P880086S309
- Device
- Endurity, Endurity Core, Assurity and Assurity +
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S309
- Product code
- DXY
- Decision date
- 2019-12-06
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Alternate supplier for the RF antenna and ribbon carrier components used in Scalable Brady Platform SR/DR pacemakers.
Current openFDA PMA Record#
- Device
- Endurity, Endurity Core, Assurity and Assurity +
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S309
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2019-12-06
- Decision code
- OK30
- Date received
- 2019-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the RF antenna and ribbon carrier components used in Scalable Brady Platform SR/DR pacemakers.