PMA P110019S121
- Device
- XIENCE Skypoint Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S121
- Product code
- NIQ
- Decision date
- 2022-06-22
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Addition of an alternate automated sheath process for the Skypoint LV.
Current openFDA PMA Record#
- Device
- XIENCE Skypoint Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S121
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-06-22
- Decision code
- OK30
- Date received
- 2022-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate automated sheath process for the Skypoint LV.