PMA P110019S001
- Device
- XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S001
- Product code
- NIQ
- Decision date
- 2012-05-07
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS, UK, LIMITED IN DERBYSHIRE, UNITED KINGDOM.
Current openFDA PMA Record#
- Device
- XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S001
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-05-07
- Decision code
- APPR
- Date received
- 2011-11-02
- 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 AT STERIGENICS, UK, LIMITED IN DERBYSHIRE, UNITED KINGDOM.