PMA P880086S271
- Device
- Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S271
- Product code
- DXY
- Decision date
- 2016-04-22
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Add an alternate supplier for the IS-1 connector assembly.
Current openFDA PMA Record#
- Device
- Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S271
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2016-04-22
- Decision code
- OK30
- Date received
- 2016-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the IS-1 connector assembly.