PMA P150003S033

Device
Synerg Everolimus Eluting Conronary Stent System
Applicant
Boston Scientific Corporation
PMA number
P150003
Supplement
S033
Product code
NIQ
Decision date
2017-09-13
Classification
Coronary Drug-eluting Stent
Generic name
Coronary drug-eluting stent
Approval order statement
Removal of a redundant inspection step.

Current openFDA PMA Record#

Device
Synerg Everolimus Eluting Conronary Stent System
Applicant
Boston Scientific Corporation
PMA number
P150003
Supplement
S033
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2017-09-13
Decision code
OK30
Date received
2017-08-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of a redundant inspection step.