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Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co

FDA premarket approval P950020/S081 · decided 2017-08-18

Approval details

PMA number
P950020
Supplement
S081
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
Boston Scientific Corp
Date received
2017-07-20
Decision date
2017-08-18
Days to decision
29 days
Decision code
OK30
Product code
NWX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Alternate degreaser used in the cleaning process for the cutting blades (atherotomes).

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