PMA P880086S301
- Device
- Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S301
- Product code
- DXY
- Decision date
- 2018-08-14
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Reduction in frequency of bioburden testing at the Penang, Malaysia manufacturing site.
Current openFDA PMA Record#
- Device
- Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S301
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-08-14
- Decision code
- OK30
- Date received
- 2018-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in frequency of bioburden testing at the Penang, Malaysia manufacturing site.