PMA P830079S014

Device: INSTAT ABSORBABLE COLLAGEN HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: P830079
Supplement: S014
Product code: LMF
Decision date: 2003-09-26
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSTAT ABSORBABLE COLLAGEN HEMOSTAT AND IS INDICATED FOR USE "IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMOLOGICAL SURGERY) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL PROCEDURES IN INEFFECTIVE OR IMPRACTICAL. INSTAT HEMOSTAT CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES."

Current openFDA PMA Record#

Device: INSTAT ABSORBABLE COLLAGEN HEMOSTAT
Applicant: ETHICON, Inc.
PMA number: P830079
Supplement: S014
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2003-09-26
Decision code: APPR
Date received: 2003-08-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSTAT ABSORBABLE COLLAGEN HEMOSTAT AND IS INDICATED FOR USE "IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMOLOGICAL SURGERY) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL PROCEDURES IN INEFFECTIVE OR IMPRACTICAL. INSTAT HEMOSTAT CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES."