PMA P110019S014
- Device
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S014
- Product code
- NIQ
- Decision date
- 2012-08-20
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED IN TIPPERARY. IRELAND.
Current openFDA PMA Record#
- Device
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S014
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-08-20
- Decision code
- APPR
- Date received
- 2012-02-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED IN TIPPERARY. IRELAND.