PMA P110043S014
- Device
- Omnilink Elite Vascular Balloon-Expandable Stent System
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S014
- Product code
- NIO
- Decision date
- 2024-09-20
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- approval for changing the bacterial endotoxin test method from gel clot to kinetic chromogenic
Current openFDA PMA Record#
- Device
- Omnilink Elite Vascular Balloon-Expandable Stent System
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S014
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2024-09-20
- Decision code
- OK30
- Date received
- 2024-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for changing the bacterial endotoxin test method from gel clot to kinetic chromogenic