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Device | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08540 |
PMA Number | P850010 |
Supplement Number | S069 |
Date Received | 02/19/2016 |
Decision Date | 03/17/2016 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |