CUTTING BALLOON
FDA premarket approval P950020/S006 · decided 2003-03-11
Approval details
- PMA number
- P950020
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CUTTING BALLOON
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific Corp
- Date received
- 2002-06-28
- Decision date
- 2003-03-11
- Days to decision
- 256 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR: 1) USE OF THE BIOSLIDE COATING ON ALL CUTTING BALLOON MODELS, AND 2) USE OF A REVISED Y-SITE ON OVER-THE-WIRE (OTW) CUTTING BALLOON MODELS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL/OTW AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED. IN ADDITION, THE TARGET LESION SHOULD POSSES THE FOLL
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