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 | COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P810006 |
Supplement Number | S022 |
Date Received | 09/30/2005 |
Decision Date | 09/20/2006 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION. |
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