PMA P110043S013
- Device
- Omnilink Elite™ Vascular Balloon-Exoandable Stent System
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S013
- Product code
- NIO
- Decision date
- 2022-09-07
- Generic name
- STENT, ILIAC
- Approval order statement
- Addition of secondary sterilization equipment.
Current openFDA PMA Record#
- Device
- Omnilink Elite™ Vascular Balloon-Exoandable Stent System
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S013
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2022-09-07
- Decision code
- OK30
- Date received
- 2022-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of secondary sterilization equipment.