Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE & FIBRILLAR FORM |
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 | S018 |
Date Received | 04/15/2003 |
Decision Date | 05/05/2003 |
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 CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT, 2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING, 3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND 4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES. |
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