CUTTING BALLOON ULTRA
FDA premarket approval P950020/S007 · decided 2003-04-30
Approval details
- PMA number
- P950020
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CUTTING BALLOON ULTRA
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific Corp
- Date received
- 2002-11-01
- Decision date
- 2003-04-30
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR DESIGN CHANGES IN THE CUTTING BALLOON, BOTH THE OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS, AND FOR MANUFACTURING CHANGES FOR THE MR CONFIGURATION. ADDITIONALLY, APPROVAL TO ADD THE TRADE NAME CUTTING BALLOON ULTRA2 FOR BOTH CONFIGURATIONS AND TO ADD WARNINGS TO THE INSTRUCTIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON ULTRA2 AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDI
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