PMA P810006S070

Device: COLLASTAT
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S070
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: COLLASTAT
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S070
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.