Avitene Microfibrillar Collagen Hemostat (MCH) Flour, Avitene Microfibrillar Collagen Hemostat (MCH) SyringeAvitene, and

FDA premarket approval N17600/S034 · decided 2022-04-01

Approval details

PMA number: N17600
Supplement: S034
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name: Avitene Microfibrillar Collagen Hemostat (MCH) Flour, Avitene Microfibrillar Collagen Hemostat (MCH) SyringeAvitene, and
Generic name: Agent, absorbable hemostatic, collagen based
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Date received: 2020-08-03
Decision date: 2022-04-01
Days to decision: 606 days
Decision code: APPR
Product code: LMF
Advisory committee: General, Plastic Surgery
Expedited review: No
Location: Warwick, RI
Statement: Approval for the replacement of current qualitative in process heavy metals testing with a quantitative test and removal of in process testing of total ash content

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Record	Firm	Date
VENTRALIGHT ST MESH (K101851)	Davol Inc., Sub. C. R. Bard, Inc.	2010-07-15
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 (K092032)	Davol Inc., Sub. C. R. Bard, Inc.	2009-12-08
BARD 3DMAX MESH (K081010)	Davol Inc., Sub. C. R. Bard, Inc.	2008-10-07
BARD COMPOSITE L/P MESH (K061754)	Davol Inc., Sub. C. R. Bard, Inc.	2006-10-23
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (K061314)	Davol Inc., Sub. C. R. Bard, Inc.	2006-06-02
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 (K051848)	Davol Inc., Sub. C. R. Bard, Inc.	2005-08-11
SALUTE FIXATION SYSTEM (K050610)	Davol Inc., Sub. C. R. Bard, Inc.	2005-05-25
AQUASENS FLUID MONITORING SYSTEM (K011069)	Davol Inc., Sub. C. R. Bard, Inc.	2001-08-16