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 | ADEPT ADHESION REDUCTION SOLUTION |
Generic Name | Barrier, absorbable, adhesion |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD MCGAW PARK, IL 60085 |
PMA Number | P050011 |
Supplement Number | S001 |
Date Received | 01/09/2008 |
Decision Date | 02/07/2008 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement RELOCATION OF THE QUALITY SYSTEM TO BAXTER AG, VIENNA, AUSTRIA AND CHANGING THE CONTRACT TEST LABORATORY TO THE MATERIAL MANUFACTURER CARGILL?S TESTING LABORATORY. |
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