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 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 | S008 |
Date Received | 01/31/2002 |
Decision Date | 03/05/2002 |
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 A MANUFACTURING FACILITY LOCATED AT KENSEY NASH CORPORATION, EXTON, PENNSYLVANIA. THE GRANULATION AND SYRINGE CUTTING PROCESSES WILL BE CONDUCTED AT THIS FACILITY. |
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