PMA P840041

Device: NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE
Applicant: Davis & Geck, Inc.
PMA number: P840041
Supplement: S006
Product code: GAS
Decision date: 1996-01-11
Generic name: Suture, nonabsorbable, synthetic, polyester
Approval order statement: APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED

Current openFDA PMA Record#

Device: NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE
Applicant: Davis & Geck, Inc.
PMA number: P840041
Supplement: S006
Product code: GAS
Generic name: Suture, nonabsorbable, synthetic, polyester
Decision date: 1996-01-11
Decision code: APPR
Date received: 1995-12-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED