PMA P110019S093
- Device
- XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S093
- Product code
- NIQ
- Decision date
- 2017-06-23
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.
Current openFDA PMA Record#
- Device
- XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S093
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2017-06-23
- Decision code
- OK30
- Date received
- 2017-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.