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ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER

FDA premarket approval P980037/S057 · decided 2016-04-22

Approval details

PMA number
P980037
Supplement
S057
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2016-03-07
Decision date
2016-04-22
Days to decision
46 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for a dual manufacturing site located at Boston Scientific Corporation, 150 Baytech Drive, San Jose, California, for final manufacturing activities, which include incoming inspection, acceptance testing, final packaging, and labeling.

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