PMA P110019S101
- Device
- XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S101
- Product code
- NIQ
- Decision date
- 2018-08-31
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- New (replicate) finished good manufacturing line.
Current openFDA PMA Record#
- Device
- XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S101
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-08-31
- Decision code
- OK30
- Date received
- 2018-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New (replicate) finished good manufacturing line.