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ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM

FDA premarket approval P980037/S040 · decided 2012-10-16

Approval details

PMA number
P980037
Supplement
S040
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2012-08-15
Decision date
2012-10-16
Days to decision
62 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR CHANGING THE PACKAGING TRAY MATERIAL FOR THE ANGIOJET ULTRA XMI, ULTRA SPIROFLEX, AND ULTRA SPIROFLEX VG THROMBECTOMY SETS FROM PETG TO PETG DENEST, AS WELL AS CHANGING THE MANUFACTURING OF THESE PACKAGING TRAYS FROM PERFECSEAL TO BROOKDALE.

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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