PMA P110019S102
- Device
- XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIEN
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S102
- Product code
- NIQ
- Decision date
- 2018-10-04
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Increase the sterilization load density with a modified configuration.
Current openFDA PMA Record#
- Device
- XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIEN
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S102
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-10-04
- Decision code
- OK30
- Date received
- 2018-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase the sterilization load density with a modified configuration.