PMA P880086S284
- Device
- Assurity, Assurity+, Endurity families of ICD Devices
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S284
- Product code
- DXY
- Decision date
- 2017-08-22
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Addition of an alternate supplier for header molds.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity families of ICD Devices
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S284
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2017-08-22
- Decision code
- OK30
- Date received
- 2017-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for header molds.