PMA P980053S016

Device: DURASPHERE INJECTABLE BULKING AGENT
Applicant: Carbon Medical Technologies, Inc.
PMA number: P980053
Supplement: S016
Product code: LNM
Decision date: 2016-04-06
Classification: Agent, Bulking, Injectable For Gastro-urology Use
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: Approval for the addition of an inspection procedure for the verification of shipments to the sterilization vendor; the addition of instructions into an existing manufacturing procedure to document sealer settings on the record; the addition of instructions into an existing manufacturing procedure to record additional information and verify the total amount of sterile water used; and to revise latex labeling in line with recent FDA guidance.

Current openFDA PMA Record#

Device: DURASPHERE INJECTABLE BULKING AGENT
Applicant: Carbon Medical Technologies, Inc.
PMA number: P980053
Supplement: S016
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2016-04-06
Decision code: APPR
Date received: 2016-03-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of an inspection procedure for the verification of shipments to the sterilization vendor; the addition of instructions into an existing manufacturing procedure to document sealer settings on the record; the addition of instructions into an existing manufacturing procedure to record additional information and verify the total amount of sterile water used; and to revise latex labeling in line with recent FDA guidance.