CUTTING BALLOON
FDA premarket approval P950020/S001 · decided 2000-11-21
Approval details
- PMA number
- P950020
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CUTTING BALLOON
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific Corp
- Date received
- 2000-10-17
- Decision date
- 2000-11-21
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A MODIFICATION TO THE DISTAL TIP OF THE CUTTING BALLOON(TM).
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510(k) clearances by this applicant
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|---|---|---|
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