PMA P910019S001

Device
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant
Intensive Technology, Inc.
PMA number
P910019
Supplement
S001
Product code
MCX
Decision date
1995-01-05
Generic name
CATHETER, CORONARY, ATHERECTOMY

Current openFDA PMA Record#

Device
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Applicant
Intensive Technology, Inc.
PMA number
P910019
Supplement
S001
Product code
MCX
Generic name
CATHETER, CORONARY, ATHERECTOMY
Decision date
1995-01-05
Decision code
APPR
Date received
1994-06-13
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material