PMA P910019S005

Device: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant: Intensive Technology, Inc.
PMA number: P910019
Supplement: S005
Product code: MCX
Decision date: 1998-02-23
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a change to the 5.5F-7.5F TEC cutter catheters, involving the addition of a spiral groove on the inner surface of the cutter component.

Current openFDA PMA Record#

Device: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant: Intensive Technology, Inc.
PMA number: P910019
Supplement: S005
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 1998-02-23
Decision code: APPR
Date received: 1998-01-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the 5.5F-7.5F TEC cutter catheters, involving the addition of a spiral groove on the inner surface of the cutter component.