PMA P150003S067

Device
SYNERGY Everolimus-Eluting Platinum Chromium Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Sten
Applicant
Boston Scientific Corporation
PMA number
P150003
Supplement
S067
Product code
NIQ
Decision date
2020-11-19
Generic name
Coronary drug-eluting stent
Approval order statement
Modification to the midshaft adhesive bond length.

Current openFDA PMA Record#

Device
SYNERGY Everolimus-Eluting Platinum Chromium Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Sten
Applicant
Boston Scientific Corporation
PMA number
P150003
Supplement
S067
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2020-11-19
Decision code
OK30
Date received
2020-11-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the midshaft adhesive bond length.