| STATUS |
Change in Regulatory Pathway for brand-name Sutures. Co. today announced that it received a letter from the US Food and Drug Administration (FDA) stating that, based on the information provided to the Agency to date by Co., its brand-based sutures will require a Premarket Approval (PMA) instead of the anticipated Premarket Notification (510(k)). The FDA cited that the new material and the manufacturing process, used by Co. to produce branded sutures, raised questions that had not been previously considered for silk sutures that would be used as a predicate device in a 510(k) submission. Co. is in ongoing discussions with the Agency regarding the scope and nature of the clinical trial as well as any other data required to support a market approval decision for brand sutures. As these discussions result in a definitive direction Co. will disclose the impact on its branded suture program. |
| UPDATE | 06.03 |
| COMPANY | This data is not available for free |
|
Want more information ? Interested in the hidden information ? Click here and do your request. |