Atlas FDA

Wolverine Coronary Cutting Balloon

FDA premarket approval P950020/S112 · decided 2021-11-02

Approval details

PMA number
P950020
Supplement
S112
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Wolverine Coronary Cutting Balloon
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
Boston Scientific Corp
Date received
2021-08-04
Decision date
2021-11-02
Days to decision
90 days
Decision code
APPR
Product code
NWX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for updates to the IFU Intended Use/Indications for Use section to remove the restriction on treatment of calcified lesions, and to revise the warning in relation to emergency surgery availability.

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