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Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System

FDA premarket approval P900056/S191 · decided 2020-11-23

Approval details

PMA number
P900056
Supplement
S191
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2020-10-22
Decision date
2020-11-23
Days to decision
32 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for a manufacturing site located at 4100 Hamline Avenue North, St. Paul, Minnesota, 55112 for the manufacture, repair, distribution and warehousing activities for the Rotablator and ROTAPRO Consoles.

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510(k) clearances by this applicant

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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