PMA P990030

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Angiotech Medical Device Technologies
PMA number: P990030
Supplement: S005
Product code: LMF
Decision date: 2004-09-13
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A NEW TRADE NAME FOR THE DEVICE PREVIOUSLY KNOWN AS THE COSTASIS/DYNASTAT SURGICAL HEMOSTAT: THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL SURGICAL HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

Current openFDA PMA Record#

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Angiotech Medical Device Technologies
PMA number: P990030
Supplement: S005
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2004-09-13
Decision code: APPR
Date received: 2004-08-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A NEW TRADE NAME FOR THE DEVICE PREVIOUSLY KNOWN AS THE COSTASIS/DYNASTAT SURGICAL HEMOSTAT: THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL SURGICAL HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.