This occurred before the device was submitted for its first 510(k) approval.
Also, companies have some discretion in what changes they re-submit to the FDA and what the decide to just document internally. There are guidelines, like if you change the OS you better resubmit, but there is a wide swath of gray area. The FDA is not looking at every code/hardware change request. They audit your process.
Also, companies have some discretion in what changes they re-submit to the FDA and what the decide to just document internally. There are guidelines, like if you change the OS you better resubmit, but there is a wide swath of gray area. The FDA is not looking at every code/hardware change request. They audit your process.
Edit: typos