PMA P110043S003
- Device
- OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYTEM
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S003
- Product code
- NIO
- Decision date
- 2012-11-16
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR AN E-BEAM STERILIZATION SITE LOCATED AT SYNERGY HEALTH IRELAND IN OFFALY, IRELAND.
Current openFDA PMA Record#
- Device
- OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYTEM
- Applicant
- Abbott Vascular-Cardiac Therapies
- PMA number
- P110043
- Supplement
- S003
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2012-11-16
- Decision code
- APPR
- Date received
- 2012-10-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN E-BEAM STERILIZATION SITE LOCATED AT SYNERGY HEALTH IRELAND IN OFFALY, IRELAND.