40 results
424B3
APYP
Appyea, Inc
26 Feb 24
Prospectus supplement
11:13am
and not raise different questions of safety or effectiveness than the predicate device.
The 510(k) clearance process can be expensive, lengthy … to maintain products after clearance. For example, as part of the Food and Drug Administration Safety and Innovation Act, or FDASIA, enacted in 2012
POS AM
APYP
Appyea, Inc
14 Feb 24
Prospectus update (post-effective amendment)
9:29am
characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness … of the Food and Drug Administration Safety and Innovation Act, or FDASIA, enacted in 2012, Congress reauthorized the Medical Device User Fee Amendments
POS AM
APYP
Appyea, Inc
8 Feb 24
Prospectus update (post-effective amendment)
3:13pm
technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness … of the Food and Drug Administration Safety and Innovation Act, or FDASIA, enacted in 2012, Congress reauthorized the Medical Device User Fee
424B3
l2v0k
21 Nov 22
Prospectus supplement
1:17pm
PRE 14A
i55n3d24 rds9
20 Sep 19
Preliminary proxy
2:46pm