LMV ansökan

01. MPA_Cover_letter

03 2020-000233-41 SE 20200707 CTA PDF Form signerat

04 OPTION LMV MPT studieprotokoll 200706signerat

05 Signatursida studieprotokoll 20200708084633081

06 Produktresumé Angusta

07 Faktureringsinformation

08 Godkännande etik 20200708095420307

01. Följebrev MPA_Begäran om komplettering

02 2020-000233-41 SE 20200817 CTA Package

2 Bilaga komplettering_2

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

Begäran om komplettering

2020-000233-41 SE 20200817 Form_Sign

LMV MPT studieprotokoll_version 4.0_ 200817_sign

_2022-09-23 Tillstånd väsentlig ändring

Acceptance to apply on behalf of the OPTION study

ANGUSTA Stability_Redacted

ANGUSTA Stability1_Redacted

Mail Mogens bekräftelse avseende LMV ansökan 220923

Shelf life extension of ANGUSTA justification_Redacted

Tillstånd Angusta

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

Följebrev LMV OPTION 221222

OPTION_Powerpoint_Vantrum_Vit

OPTION_Powerpoint_Vantrum

OPTION_Rollup_850x2000

Signering FPI OPTION 221222

substantial_amendment_notification_form__0 OPTION 221222

Tillstånd 6.2.1-2022-051529 Tamro AB Importgatan tillverkning prövningsläkemedel människa

2023-01-30 Begäran om komplettering väsentlig ändring

02 OPTION studieprotokoll_v11.1_230207_marked

02 OPTION studieprotokoll_v11.1_230207

2023-02-10 Tillstånd väsentlig ändring 2020-000233-41

Bilaga begäran om komplettering väsentlig ändring

Följebrev LMV OPTION 230207

substantial_amendment_notification_form__0 OPTION 230207

00 Notification form Clinical investigation of medical devices

01 Invoice documentation

02 OPTION LMV MPT studieprotokoll_v5

03 2020-000233-41 SE 20200707 CTA PDF Form signerat

04 Investigators Brochure_Coloplast balloon catheter_modifiedID16FEB2021

05 Insurance policy

06 Subject information and consent forms

09 Declaration letter – Sweden investigational device X-Flow Prostatectomy catheter short tip silicone

10 Godkännande etik 20200708095420307

11 Godkännande LMV Angusta

Tillstånd 5.1-2021-14812

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

Tillstånd amendment 5.1-2021-14812

2022-03-31 Tillstånd amendment 5.1-2021-14812[1]

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 LMV MPT studieprotokoll_v8_marked

02 OPTION LMV MPT studieprotokoll_v8

Bruksanvisning Coloplast svenska

Följebrev_210407

Följebrev_210415

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

Följebrev LMV OPTION 221222

OPTION_Powerpoint_Vantrum_Vit

OPTION_Powerpoint_Vantrum

OPTION_Rollup_850x2000

Signering FPI OPTION 221222

substantial_amendment_notification_form__0 OPTION 221222

Tillstånd 6.2.1-2022-051529 Tamro AB Importgatan tillverkning prövningsläkemedel människa

2023-01-30 Begäran om komplettering väsentlig ändring

02 OPTION studieprotokoll_v11.1_230207

2023-02-10 Tillstånd amendment 5.1-2021-14812

Bilaga begäran om komplettering väsentlig ändring

Följebrev LMV OPTION 230207

substantial_amendment_notification_form__0 OPTION 230207