USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL

FDA premarket approval P790017/S061 · decided 1997-03-03

Approval details

PMA number

P790017

Supplement

S061

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL

Generic name

Catheters, transluminal coronary angioplasty, percutaneous

Applicant

Medtronic, Ireland

Date received

1997-01-27

Decision date

1997-03-03

Days to decision

35 days

Decision code

APPR

Product code

LOX

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR ADDITIONAL QUARTER MILLIMETER DIAMETER SIZE MODELS OF THE PROCROSS(TM) CATHETER LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME USCI(R) PROCROSS(TM) OVER-THE-WIRE DILATATION CATHETER WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.

510(k) clearances by this applicant