PMA P110019S104
- Device
- XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Everolimus Eluting Coronary Stent Systems;XIENCE Alpin and Sierra Everol
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S104
- Product code
- NIQ
- Decision date
- 2019-02-20
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Add a third sterilization chamber at the contract sterilizer.
Current openFDA PMA Record#
- Device
- XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Everolimus Eluting Coronary Stent Systems;XIENCE Alpin and Sierra Everol
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S104
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2019-02-20
- Decision code
- OK30
- Date received
- 2019-01-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a third sterilization chamber at the contract sterilizer.