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 | CollaPlug®, Absorbable Collagen Wound Dressing for Dental Surgery |
Generic Name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P840062 |
Supplement Number | S059 |
Date Received | 12/21/2016 |
Decision Date | 01/19/2017 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Clearance for the manufacturing process change for CollaPlug Absorbable Wound Dressings for Dental Surgery: elimination of the first percent solids test following dispersion preparation and reliance upon the second percent solids test, which occurs further down the process, after the centrifugation step and before the lyophilization step. |
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