FDA.reportPublic FDA data

PMA P060006S097

Device
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P060006
Supplement
S097
Product code
NIN
Decision date
2019-07-25
Classification
Stent, Renal
Generic name
STENT, RENAL
Approval order statement
Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.

Current openFDA PMA Record#

Device
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P060006
Supplement
S097
Product code
NIN
Generic name
STENT, RENAL
Decision date
2019-07-25
Decision code
OK30
Date received
2019-06-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.