PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-

FDA premarket approval P110010/S096 · decided 2015-06-01

Approval details

PMA number

P110010

Supplement

S096

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-

Generic name

Coronary drug-eluting stent

Applicant

Boston Scientific Corp

Date received

2014-09-30

Decision date

2015-06-01

Days to decision

244 days

Decision code

APPR

Product code

NIQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

Statement

APPROVAL FOR THE PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUMCORONARY STENT SYSTEMS (MONORAIL AND OVER-THE-WIRE). THESE DEVICES ARE INDICATED FORIMPROVING LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATICHEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES>=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.

510(k) clearances by this applicant