PMA P980037S083

Device
AngioJet Rheolytic Thrombectomy System
Applicant
Boston Scientific Corp
PMA number
P980037
Supplement
S083
Product code
MCX
Decision date
2020-11-12
Generic name
CATHETER, CORONARY, ATHERECTOMY
Approval order statement
Changes to incoming inspections.

Current openFDA PMA Record#

Device
AngioJet Rheolytic Thrombectomy System
Applicant
Boston Scientific Corp
PMA number
P980037
Supplement
S083
Product code
MCX
Generic name
CATHETER, CORONARY, ATHERECTOMY
Decision date
2020-11-12
Decision code
OK30
Date received
2020-11-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to incoming inspections.