FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX
FDA premarket approval P950020/S055 · decided 2013-06-28
Approval details
- PMA number
- P950020
- Supplement
- S055
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- Boston Scientific Corp
- Date received
- 2012-10-10
- Decision date
- 2013-06-28
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR DIRECTIONS FOR USE (DFU) LABELING MODIFICATIONS.
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