PMA P880027S037

Device
SCHNEIDER FREEHAND(R) PTCA CATHETERS
Applicant
Boston Scientific
PMA number
P880027
Supplement
S037
Product code
LOX
Decision date
1995-07-31
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
APPROVAL FOR ADDITIONAL QUARTER SIZE MODELS OF THE MC RAIL, MYSTIC, & FREEHAND CATHETER LINES

Current openFDA PMA Record

Device
SCHNEIDER FREEHAND(R) PTCA CATHETERS
Applicant
Boston Scientific
PMA number
P880027
Supplement
S037
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1995-07-31
Decision code
APPR
Date received
1995-05-22
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR ADDITIONAL QUARTER SIZE MODELS OF THE MC RAIL, MYSTIC, & FREEHAND CATHETER LINES

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