PMA P910019S003

Device: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant: Intensive Technology, Inc.
PMA number: P910019
Supplement: S003
Product code: MCX
Decision date: 1998-01-29
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a change to the 5.5F TEC(R) cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.

Current openFDA PMA Record#

Device: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant: Intensive Technology, Inc.
PMA number: P910019
Supplement: S003
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 1998-01-29
Decision code: APPR
Date received: 1997-10-28
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change to the 5.5F TEC(R) cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.