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WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE)

FDA premarket approval P950020/S079 · decided 2017-02-09

Approval details

PMA number
P950020
Supplement
S079
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE)
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
Boston Scientific Corp
Date received
2016-11-30
Decision date
2017-02-09
Days to decision
71 days
Decision code
APPR
Product code
NWX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for a manufacturing site located at Boston Scientific Corporation, Two Scimed Place, Maple Grove, Minnesota, for the ZGlide manufacturing process and application.

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510(k) clearances by this applicant

RecordFirmDate
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WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21