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 | DRILAC CUBES AND GRANULES |
Generic Name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
Applicant | OSMED, INC. 325 LAKE AVE. SOUTH - SUITE #608 DULUTH, MN 55802 |
PMA Number | P800012 |
Supplement Number | S009 |
Date Received | 08/12/2002 |
Decision Date | 09/17/2002 |
Withdrawal Date
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04/25/2007 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW MANUFACTURING AND STERILIZATION SITES. THE MANUFACTURING SITE IS LOCATED AT KENSEY NASH CORPORATION, EXTON, PA. THE NEW STERILIZATION SITE IS LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NJ. |
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