01 · STRAT · MERIDIAN · WORKBENCH
Regulatory pathway · 7 APAC jurisdictions
Pathway sealed 12 Mar · PMDA anchor · Reveal LINQ predicate
Agent reasoning trace · MERIDIAN
Case opened · MEDTRONIC-ICM-001 · Class III ICM091a…0001
04 Mar 09:00 JST142 guidance documents ingested (PMDA · EU MDR · ISO)b71e…4a29
05 Mar 16:05 JSTIntended use locked · AF detection · adults ≥1817fa…ec88
08 Mar 11:40 JSTSequencing model run · 3 pathway options surfaced82e1…9b3c
10 Mar 14:22 JSTPathway sealed · PMDA anchor · human sign-off A. Tanakad52b…0f17
12 Mar 09:42 JSTJurisdiction pathway matrix
JP · PMDAANCHOR · Class III · PMB/SD No.1228
SG · HSAReliance on PMDA milestone
AU · TGAReliance · ARTG conformity
TW · TFDAReliance · Day 28/72 track
KR · KFDAIndependent HTA · predicate accepted
CN · NMPALocal clinical trial required · 18mo
HKReliance · light-touch registration
Predicate substantiation · Reveal LINQ
PREDICATEMedtronic Reveal LINQ (cleared)
CLAIMSubstantial equivalence · indication-narrowed
EVIDENCE6-yr post-market dataset · 4,217 events
STATUSaccepted across 6 of 7 markets
Governance
Receipt chain
Pathway sealedd52b…0f17
Intended use locked17fa…ec88
Sequencing model82e1…9b3c
Human sign-offs
Akira Tanaka · Strategy approval12 Mar · ✓
Framework parity
PMDAHSATGATFDAKFDANMPA21 CFR Part 11