LMV ansökan
01. Följebrev MPA_Begäran om komplettering
02 2020-000233-41 SE 20200817 CTA Package
03 2020-000233-41 SE 20200817 Form_Signerad version
04 OPTION LMV MPT studieprotokoll_version 4.0_ 200817
05 OPTION LMV MPT studieprotokoll_version 4.0_200817_signatursida
06 OPTION Märkningstext studieläkemedel_version 1.0 20200810
02 OPTION studieprotokoll_v11_221222_marked
02 OPTION studieprotokoll_v11_221222
6.1_DSMB-Charter-OPTION_v3_221222_marked
6.1_DSMB-Charter-OPTION_v3_221222
Certificate of GMP-compliance Gothenburg
FPI_Kvinnan RCT_OPTION v4 221222_marked
FPI_Kvinnan RCT_OPTION v4 221222
FPI_Partner RCT_OPTION v2 221222_marked
FPI_Partner RCT_OPTION v2 221222
substantial_amendment_notification_form__0 OPTION 221222
Tillstånd 6.2.1-2022-051529 Tamro AB Importgatan tillverkning prövningsläkemedel människa
- Coloplast 5.1-2021-14812
- Amendment 1 5.1-2022-14252
- Komplettering 1
- Komplettering 2
- Amendment 2 5.1-2023-596
- Komplettering
00 Notification form Clinical investigation of medical devices
02 OPTION LMV MPT studieprotokoll_v5
03 2020-000233-41 SE 20200707 CTA PDF Form signerat
04 Investigators Brochure_Coloplast balloon catheter_modifiedID16FEB2021
06 Subject information and consent forms
1_02 OPTION LMV MPT studieprotokoll_v10_220211
2_02 OPTION LMV MPT studieprotokoll_v10_220211_marked
3_Bi 6.2 OPTION Kvinnan ENKÄT 2 220211
4_FPI_Kvinnan RCT_OPTION 220211
5.1_Patientinformation om induktion med Coloplast_220211
5.2_Patientinformation om induktion med Cook_220211
5.3_Patientinformation om induktion med läkemedel Angusta_ickePROM 220211
5.4_Patientinformation om induktion med läkemedel Angusta_PROM 220211
6.1_DSMB-Charter-OPTION_v2_211108
6.2_conflict-of-interest-confidentiality-statement-508C
02 OPTION LMV MPT studieprotokoll_v6
Begäran om komplettering 5.1-2021-14812
Bilaga komplettering 5.1-2021-14812
Bruksanvisning Coloplast svenska
EC declaration of conformity Coloplast #288 X-FLOW Prostatectomy Catheter Silicone
Essential Requirements – Coloplast Silicone Prostatic Catheter (003)
Investigators Brochure_Coloplast balloon catheter_modifiedID
02 OPTION studieprotokoll_v11_221222_marked
02 OPTION studieprotokoll_v11_221222
6.1_DSMB-Charter-OPTION_v3_221222_marked
6.1_DSMB-Charter-OPTION_v3_221222
Certificate of GMP-compliance Gothenburg
FPI_Kvinnan RCT_OPTION v4 221222_marked
FPI_Kvinnan RCT_OPTION v4 221222
FPI_Partner RCT_OPTION v2 221222_marked
FPI_Partner RCT_OPTION v2 221222
substantial_amendment_notification_form__0 OPTION 221222
Tillstånd 6.2.1-2022-051529 Tamro AB Importgatan tillverkning prövningsläkemedel människa