|
Device | SUPARTZ |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | SEIKAGAKU CORP. 6-1, MARUNOUCHI 1-CHOME, CHIYODA-KU TOKYO 100-0-0005 |
PMA Number | P980044 |
Supplement Number | S005 |
Date Received | 08/01/2006 |
Decision Date | 02/13/2007 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ELIMINATION OF A STEP IN THE ACTIVE INGREDIENT SODIUM HYALURONATE MANUFACTURING PROCESS AND MOVING THAT MANUFACTURING PROCESS FROM THE CURRENT TWO BUILDINGS TO A NEW WING IN AN EXISTING BUILDING. |