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 | SURGICEL ABSORBABLE HEMOSTAT |
Generic Name | Agent, absorbable hemostatic, non-collagen based |
Regulation Number | 878.4490 |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | N12159 |
Supplement Number | S028 |
Date Received | 08/15/2011 |
Decision Date | 09/15/2011 |
Product Code |
LMG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF NEW PACKAGING EQUIPMENT. |
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