PMA P980053S003

Device: DURASPHERE INJECTABLE BULKING AGENT
Applicant: Carbon Medical Technologies, Inc.
PMA number: P980053
Supplement: S003
Product code: LNM
Decision date: 2001-04-02
Classification: Agent, Bulking, Injectable For Gastro-urology Use
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: APPROVAL TO REVISE LABELING'S DIRECTIONS FOR USE TO ADD INSTRUCTIONS FOR INJECTION OF DURASPHERE(R) VIA A PERIURETHRAL ROUTE.

Current openFDA PMA Record#

Device: DURASPHERE INJECTABLE BULKING AGENT
Applicant: Carbon Medical Technologies, Inc.
PMA number: P980053
Supplement: S003
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2001-04-02
Decision code: APPR
Date received: 2001-03-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO REVISE LABELING'S DIRECTIONS FOR USE TO ADD INSTRUCTIONS FOR INJECTION OF DURASPHERE(R) VIA A PERIURETHRAL ROUTE.