|Approval Order Statement |
The 30-day notice requested approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chambera t griffith microscience, the same sterilization contractor approved in the firm's original pma. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times.