PMA P110043S008
- Device
- OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S008
- Product code
- NIO
- Decision date
- 2014-10-09
- Generic name
- STENT, ILIAC
- Approval order statement
- CHANGE TO THE PYROGEN TESTING PROCESS.
Current openFDA PMA Record#
- Device
- OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S008
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2014-10-09
- Decision code
- OK30
- Date received
- 2014-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PYROGEN TESTING PROCESS.