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ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

FDA premarket approval P900056/S061 · decided 2001-04-13

Approval details

PMA number
P900056
Supplement
S061
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2001-03-16
Decision date
2001-04-13
Days to decision
28 days
Decision code
OK30
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
CHANGE IN THE VENDOR FOR WATER FOR INJECTION (WFI) WHICH IS A COMPONENT OF THE ROTAGLIDE(TM) LUBRICANT AND IS USED IN THE ROTABLATOR SYSTEM. FRESENIUS KABI WILL PRODUCE WFI AT THEIR FACILITY IN ACCORDANCE WITH USP SPECIFICATIONS.

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510(k) clearances by this applicant

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IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
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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