CUTTING BALLOON MONORAIL
FDA premarket approval P950020/S004 · decided 2002-02-15
Approval details
- PMA number
- P950020
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CUTTING BALLOON MONORAIL
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific Corp
- Date received
- 2001-09-17
- Decision date
- 2002-02-15
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A RAPID EXCHANGE VERSION OF THE CUTTING BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL AND IS INDICATED FOR DILATATION OF STENOSIS 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 FOLLOWING CHARACTERISTICS: DISCRETE (<=15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH); WITH A R
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