PMA P850010S069

Device: HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S069
Product code: LMF
Decision date: 2016-03-17
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.

Current openFDA PMA Record#

Device: HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P850010
Supplement: S069
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-03-17
Decision code: OK30
Date received: 2016-02-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.