USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE

FDA premarket approval P790017/S065 · decided 1998-03-23

Approval details

PMA number

P790017

Supplement

S065

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE

Generic name

Catheters, transluminal coronary angioplasty, percutaneous

Applicant

Medtronic, Ireland

Date received

1998-02-12

Decision date

1998-03-23

Days to decision

39 days

Decision code

APPR

Product code

LOX

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

Approval for a new PTCA catheter line. The device, as modified, will be marketed under the trade name USCI(R) Apollo(TM) Rely(R) SP Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel(R) Coating and Miniquet Device and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosisfor the purpose of improving myocardial perfusion.

510(k) clearances by this applicant