EXAMINER BUNDLE · POL-BUNDLE-V2
Auto-assembled regulatory dossier · per-jurisdiction
MEDTRONIC-ICM-001 · 7 jurisdictions · 847 pages aggregate · accumulating live
| Artifact | Pages | Status | Receipt |
|---|---|---|---|
| Dossier · Core | |||
| CER v17 | 312 pages | sealed 02 May | 3e7c…8b29 |
| IFU · EN + JA executable | 18 pages | sealed 12 Apr | a91d…3f47 |
| Risk file v4 · ISO 14971 | 42 pages | sealed 08 Apr | b8e2…5c61 |
| Value-claims pack | 24 pages | sealed 16 Apr | c44a…99d2 |
| PMCF protocol · 3-yr / 312 patients across 8 sites | 16 pages | sealed 28 Mar | d72f…1188 |
| Dossier · Annex | |||
| Annex 84-1 PMDA-specific | 84 pages | sealed 14 Apr | e51c…0a3b |
| Reveal LINQ predicate substantiation | 62 pages | sealed 06 Apr | f23d…7e08 |
| Supporting | |||
| 142 guidance documents ingested | — | sealed 05 Mar | b71e…4a29 |
| 78 sensitivity scan scenarios | — | partial 17 May | building… |
| 6-yr Reveal LINQ post-market data | 4,217 ev | linked 07 Mar | d52b…0f17 |