FDA.reportPublic FDA data

PMA P980037S086

Device
AngioJet Thrombectomy System
Applicant
Boston Scientific Corp
PMA number
P980037
Supplement
S086
Product code
MCX
Decision date
2021-08-12
Generic name
CATHETER, CORONARY, ATHERECTOMY
Approval order statement
Approval for a manufacturing site located at Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, MN 32577 in order to perform release/acceptance, labeling, packaging, repair/servicing, and distribution activities.

Current openFDA PMA Record#

Device
AngioJet Thrombectomy System
Applicant
Boston Scientific Corp
PMA number
P980037
Supplement
S086
Product code
MCX
Generic name
CATHETER, CORONARY, ATHERECTOMY
Decision date
2021-08-12
Decision code
APPR
Date received
2021-08-04
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, MN 32577 in order to perform release/acceptance, labeling, packaging, repair/servicing, and distribution activities.