PMA P110019S047

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S047
Product code: NIQ
Decision date: 2014-04-23
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR AN UPDATE TO THE LABELING FOR THE XIENCE XPEDITION RX (RAPID EXCHANGE) AND OTW (OVER-THE-WIRE) TO CHANGE THE GUIDING CATHETER COMPATIBILITY FOR THE 4.0MM BALLOON DIAMETER SIZES FROM A MINIMUM OF A 6 FRENCH (F) GUIDE CATHETER TO 5F FOR THE 4.0 X 8-33MM SIZES.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S047
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-04-23
Decision code: APPR
Date received: 2013-05-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN UPDATE TO THE LABELING FOR THE XIENCE XPEDITION RX (RAPID EXCHANGE) AND OTW (OVER-THE-WIRE) TO CHANGE THE GUIDING CATHETER COMPATIBILITY FOR THE 4.0MM BALLOON DIAMETER SIZES FROM A MINIMUM OF A 6 FRENCH (F) GUIDE CATHETER TO 5F FOR THE 4.0 X 8-33MM SIZES.