Tuesday, May 31, 2022 9:19:44 AM
i know the process, i work for a cardiac device company and our device took 5 years to be approved through PMA, so, yes a 510k can take several years. Maybe RMSLs is different because of the information FDA was requesting but stay in your lane buddy because ive been doing this as my job for years and yearsssssssssss
Recent RMSL News
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2026 03:14:41 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 04/15/2026 09:26:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2026 08:38:01 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/14/2025 07:03:19 PM
- Deltawave(TM) Launch Plan • ACCESS Newswire • 10/01/2025 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 05:17:46 PM
