PMA P110019
- Device
- XIENCE PROS Everolimus Eluting Coronary Stent System (XIENCE PRO5); XIENCE Skypoint Everolimus Eluting Coronary Stent Sy
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S122
- Product code
- NIQ
- Decision date
- 2026-08-28
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- changes to label printing process for secondary packaging
Current openFDA PMA Record#
- Device
- XIENCE PROS Everolimus Eluting Coronary Stent System (XIENCE PRO5); XIENCE Skypoint Everolimus Eluting Coronary Stent Sy
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S144
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-08-28
- Decision code
- OK30
- Date received
- 2026-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to label printing process for secondary packaging