SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER
FDA premarket approval P880027/S036 · decided 1995-11-21
Approval details
- PMA number
- P880027
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1995-05-19
- Decision date
- 1995-11-21
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- 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 T
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