PMA P980037S087

Device
AngioJet Thrombectomy System
Applicant
Boston Scientific Corp
PMA number
P980037
Supplement
S087
Product code
MCX
Decision date
2022-02-09
Generic name
CATHETER, CORONARY, ATHERECTOMY
Approval order statement
Modification of a core pin and cooling pin for supplied components.

Current openFDA PMA Record#

Device
AngioJet Thrombectomy System
Applicant
Boston Scientific Corp
PMA number
P980037
Supplement
S087
Product code
MCX
Generic name
CATHETER, CORONARY, ATHERECTOMY
Decision date
2022-02-09
Decision code
OK30
Date received
2022-02-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification of a core pin and cooling pin for supplied components.