PMA P110019S120
- Device
- XIENCE Skypoint Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S120
- Product code
- NIQ
- Decision date
- 2022-05-06
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval of the protocol for the post-approval study.
Current openFDA PMA Record#
- Device
- XIENCE Skypoint Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S120
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-05-06
- Decision code
- APPR
- Date received
- 2022-04-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study.