FDA.reportPublic FDA data

PMA P170023S005

Device
Bulkamid Urethral Bulking System
Applicant
Boston Scientific Corporation
PMA number
P170023
Supplement
S005
Product code
LNM
Decision date
2020-12-02
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement
Approval for minor changes to the Bulkamid Needle, including a change in the manufacturer for the Bulkamid Needle, which includes minor changes to the needle hubs outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch.

Current openFDA PMA Record#

Device
Bulkamid Urethral Bulking System
Applicant
Boston Scientific Corporation
PMA number
P170023
Supplement
S005
Product code
LNM
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date
2020-12-02
Decision code
APPR
Date received
2020-09-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor changes to the Bulkamid Needle, including a change in the manufacturer for the Bulkamid Needle, which includes minor changes to the needle hubs outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch.