PMA P110043S012
- Device
- Omnilink Elite OTW Stent System
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S012
- Product code
- NIO
- Decision date
- 2020-09-11
- Generic name
- STENT, ILIAC
- Approval order statement
- Change the resin of a molded component on the delivery system.
Current openFDA PMA Record#
- Device
- Omnilink Elite OTW Stent System
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S012
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2020-09-11
- Decision code
- OK30
- Date received
- 2020-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the resin of a molded component on the delivery system.