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NOTICESDocket No. 97P-0354, CDRH994. Orthopedic Devices; Reclassification of the Shoulder Joint Metal/Polymer/Metal Non-constrained or Semi-Constrained Porous-Coated Uncemented Prosthesis. Pages 29043-29046 [FR Doc. 99-13470] [TXT] [PDF] Written comments by August 26, 1999.
Docket Nos. 98E-0485, -0850; OC99129. Determination of Regulatory Review Period for Purposes of Patent Extension; Therma Choice Uterine Ballon Therapy System. Pages 29046-29047 [FR Doc. 99-13671][TXT] [PDF]
OC99117. Active Pharmaceutical Ingredient Workshop. Page 29047 [FR Doc. 99-13559] [TXT] [PDF]
Docket 99D-1269, CDRH9922. Medical Devices; Draft Guidance on Quality Systems Inspections Technique; Availability. Page 29048 [FR Doc. 99-13558][TXT] [PDF] Written comments by August 26, 1999.
The Guidance