STINGER SM ABLATION CATHETER

FDA premarket approval P000020/S004 · decided 2001-10-10

Approval details

PMA number

P000020

Supplement

S004

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

STINGER SM ABLATION CATHETER

Generic name

Cardiac ablation percutaneous catheter

Applicant

Boston Scientific Corp

Date received

2001-08-24

Decision date

2001-10-10

Days to decision

47 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Lowell, MA

Statement

APPROVAL FOR THE ADDITION OF ANOTHER ABLATION CATHETER MODEL TO THE EXISTING STINGER(TM) PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STINGER(TM) SM ABLATION CATHETER AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC STIMULI.

510(k) clearances by this applicant