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AngioJet Rheolytic Thrombectomy System, AngioJet Ultra XMI/AngioJet Ultra Spiroflex/AngioJet Ultra Distaflex Thrombectom

FDA premarket approval P980037/S070 · decided 2018-10-02

Approval details

PMA number
P980037
Supplement
S070
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AngioJet Rheolytic Thrombectomy System, AngioJet Ultra XMI/AngioJet Ultra Spiroflex/AngioJet Ultra Distaflex Thrombectom
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2018-09-04
Decision date
2018-10-02
Days to decision
28 days
Decision code
OK30
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Changes to the incoming inspection process for the pump body component.

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