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ROTAGLIDE(TM) LUBRICANT

FDA premarket approval P900056/S045 · decided 2000-06-06

Approval details

PMA number
P900056
Supplement
S045
Supplement type
30-Day Notice
Trade name
ROTAGLIDE(TM) LUBRICANT
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2000-05-18
Decision date
2000-06-06
Days to decision
19 days
Decision code
OK30
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
CHANGES IN THE MANUFACTURING PROCESS, REMOVING ONE OF THE STEPS FROM THE RELEASE CRITERIA FOR ROTAGLIDE(TM) LUBRICANT, TO MOVE THE PACKAGING INSPECTION AND REVIEW OF THE CERTIFICATE OF ANALYSIS FROM BOSTON SCIENTIFIC CORP. NORTHWEST TO BOSTON SCIENTIFIC CORP'S MARINA BAY DISTRIBUTION CENTER IN QUINCY, MASSECHUSETTS.

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510(k) clearances by this applicant

RecordFirmDate
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
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
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