PMA P880027S036

Device: SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER
Applicant: Boston Scientific
PMA number: P880027
Supplement: S036
Product code: LOX
Decision date: 1995-11-21
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR THE FOLLOWING:1)NEW LABELING WHICH COMPLIES TO THE FDA'S PTCA PACKAGE INSERT TEMPLATE 2)ALTERNATIVE PACKAGING DESIGN AND MATERIALS 3)A CHANGE IN THE MATERIAL OF THE PROXIMAL TO DISTAL INNER MEMBER TRANSITION SLEEVE 4)ADDITION OF 2.25, 2.75, 3.25, AND 3.75 MM BALLOONS WITH LENGTHS OF 20, 30, AND 40MM 5)AN INCREASE IN THE INNER AND OUTER DIAMETERS OF THE PROXIMAL SHAFT AND DISTAL STEM OF THE CATHETERS HAVING 20 MM BALLOONS 6)AN ALTERNATIVE DESIGN CONFIGURATION WHICH PLACES THE SHAFT TO STEM BOND DISTAL TO THE INNER MEMBER HYPOTUBE TRANSITION, NOT PROXIMAL

Current openFDA PMA Record

Device: SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER
Applicant: Boston Scientific
PMA number: P880027
Supplement: S036
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1995-11-21
Decision code: APPR
Date received: 1995-05-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING:1)NEW LABELING WHICH COMPLIES TO THE FDA'S PTCA PACKAGE INSERT TEMPLATE 2)ALTERNATIVE PACKAGING DESIGN AND MATERIALS 3)A CHANGE IN THE MATERIAL OF THE PROXIMAL TO DISTAL INNER MEMBER TRANSITION SLEEVE 4)ADDITION OF 2.25, 2.75, 3.25, AND 3.75 MM BALLOONS WITH LENGTHS OF 20, 30, AND 40MM 5)AN INCREASE IN THE INNER AND OUTER DIAMETERS OF THE PROXIMAL SHAFT AND DISTAL STEM OF THE CATHETERS HAVING 20 MM BALLOONS 6)AN ALTERNATIVE DESIGN CONFIGURATION WHICH PLACES THE SHAFT TO STEM BOND DISTAL TO THE INNER MEMBER HYPOTUBE TRANSITION, NOT PROXIMAL