PMA P110019S119
- Device
- XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems; XIENCE Xpedition, XIENCE Xpedition SV, XIENCE X
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S119
- Product code
- NIQ
- Decision date
- 2021-11-19
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Addition of an alternate automated sheath processing.
Current openFDA PMA Record#
- Device
- XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems; XIENCE Xpedition, XIENCE Xpedition SV, XIENCE X
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S119
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-11-19
- Decision code
- OK30
- Date received
- 2021-10-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate automated sheath processing.