PMA P060006S105

Device: Express SD Renal Monorail Premounted Stent System
Applicant: Boston Scientific Corp
PMA number: P060006
Supplement: S105
Product code: NIN
Decision date: 2023-03-02
Classification: Cardiovascular
Generic name: STENT, RENAL
Approval order statement: Approval for a change to approve an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents delivery system.

Current openFDA PMA Record#

Device: Express SD Renal Monorail Premounted Stent System
Applicant: Boston Scientific Corp
PMA number: P060006
Supplement: S105
Product code: NIN
Generic name: STENT, RENAL
Decision date: 2023-03-02
Decision code: APPR
Date received: 2022-12-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to approve an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents delivery system.