PMA P910019S004

Device: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant: Intensive Technology, Inc.
PMA number: P910019
Supplement: S004
Product code: MCX
Decision date: 1998-12-30
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a change to the TEC System Power Pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, LM1014N-2) with new digital circuitry (integrated circuit microcontroller, PIC16C711).

Current openFDA PMA Record#

Device: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant: Intensive Technology, Inc.
PMA number: P910019
Supplement: S004
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 1998-12-30
Decision code: APPR
Date received: 1997-10-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the TEC System Power Pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, LM1014N-2) with new digital circuitry (integrated circuit microcontroller, PIC16C711).