DURASPHERE INJECTABLE BULKING AGENT

FDA premarket approval P980053/S016 · decided 2016-04-06

Approval details

PMA number

P980053

Supplement

S016

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

DURASPHERE INJECTABLE BULKING AGENT

Generic name

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant

Carbon Medical Technologies, Inc.

Date received

2016-03-09

Decision date

2016-04-06

Days to decision

28 days

Decision code

APPR

Product code

LNM

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

St. Paul, MN

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.

510(k) clearances by this applicant