SCORPION/SCORPION M ABLATION CATHETER

FDA premarket approval P000020/S010 · decided 2006-02-16

Approval details

PMA number

P000020

Supplement

S010

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SCORPION/SCORPION M ABLATION CATHETER

Generic name

Cardiac ablation percutaneous catheter

Applicant

Boston Scientific Corp

Date received

2005-06-10

Decision date

2006-02-16

Days to decision

251 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Lowell, MA

Statement

APPROVAL FOR THE ADDITION OF A SECOND ARTICULATION TO THE STINGER S/STINGER SM LINE OF RF ABLATION CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCORPION/SCORPION M, AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI. IN ADDITION, APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE OF THE TEMPLINK/ TEMPLINK M CONNECTION CABLE

510(k) clearances by this applicant