Hi Scarlett30 - the application had to be resubmitted, which...

Hi Scarlett30 - the application had to be resubmitted, which means June is not the actual submission date. October is the best guess, meaning it's still 6-7 month mark. Going into the "Interactive review" means there are no significant issues. From the website:

Interactive Review

If the Lead Reviewer chooses to continue with anInteractive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the Medical Device User Fee Amendment (MDUFA) timeframe and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during theInteractive Review using tools such as:

• Email
• Telephone Call

DuringInteractive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the FDA.

Additionally, just before this section, is the section that states it takes one of two paths. We've gone down the the good path. Approval is close!

TheSubstantive Interactioncommunication is typically:

• an email stating that FDA will proceed to resolve any outstanding deficiencies viaInteractiveReview; or
• anAdditional Information(AI) request which places the submission on hold.

Full process here:
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process