PMA P110019S054
- Device
- XIENCE PRIME AND XIENCE PRINCE LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S054
- Product code
- NIQ
- Decision date
- 2013-10-28
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- XIENCE PRIME AND XIENCE PRINCE LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S054
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-10-28
- Decision code
- OK30
- Date received
- 2013-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.