FINISHING WIRE UNIVERSAL

FDA premarket approval P010012/S013 · decided 2003-06-09

Approval details

PMA number

P010012

Supplement

S013

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

FINISHING WIRE UNIVERSAL

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

Boston Scientific Corp

Date received

2003-04-25

Decision date

2003-06-09

Days to decision

45 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

APPROVAL FOR MODIFICATIONS TO THE FINISHING WIRE CAP SECTION OF THE COMMERCIALLY AVAILABLE FINISHING WIRE UNIVERSAL WHICH WILL ALLOW IT TO BE COMPATIBLE WITH THE IS-1 TERMINAL PIN AS WELL AS THE LV-1 TERMINAL PIN OF THE EASYTRAK LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FINISHING WIRE UNIVERSAL, MODELS 6001-6007 AND IS INDICATED FOR USE WITH GUIDANT CORONARY VENDUS LEADS.

510(k) clearances by this applicant