PMA N17600S015

Device: AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S015
Product code: LMF
Decision date: 1998-08-10
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flur, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.

Current openFDA PMA Record#

Device: AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S015
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 1998-08-10
Decision code: OK30
Date received: 1998-07-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flur, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.