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Alvimedica Management
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Interventional Cardiology
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ALVIMEDICA ACADEMY
REGULATORY DOCUMENTS
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INTERVENTIONAL CARDIOLOGY
DES – Cre8™EVO
IFU
Rev. 4 ( Revision date is 10.2019)
Rev. 5 ( Revision date is 05.2021)
Rev. 6 ( Revision date is 09.2021)
Rev. 7 ( Revision date is 05.2022)
Patient Info Leaflet (Revision Date 12.2021)
CE
CE Cre8 EVO
DoC
DoC Cre8 EVO
DES – Cre8™
IFU
Rev. 4 ( Revision date is 10.2019)
Rev. 5 ( Revision date is 05.2021)
Rev. 6 ( Revision date is 09.2021)
Rev. 7 ( Revision date is 05.2022)
Patient Info Leaflet (Revision Date 12.2021)
CE
CE Cre8 EVO
DoC
DoC Cre8 EVO
Balloon - Fluydo™
IFU
Rev. 9 (Revision date is 09.2020)
Rev. 10 (Revision date is 08.2021)
CE
CE Fluydo Pegaso
DoC
DoC Fluydo Pegaso
Balloon - Invader™ PTCA Improved Performance
IFU
Rev.15 (Revision date is 03.2021)
Rev.16 (Revision date is 04.2021)
Rev.17 (Revision date is 01.2023)
Rev.00 (Revision date is 03.2023)_EU 2017-745
Leaflet Rev.00 (Revision date is 31.08.2023) EU 2017-745
CE
CE - Invader PTCA for 93-42-EEC (MDD)
Extension Letter-EU 2023-603
CE - Invader PTCA for EU 2017-745 (MDR)
DoC
DoC Invader PTCA for 93-42-EEC (MDD)
DoC Invader PTCA for EU 2017-745 (MDR)
Balloon - ProHP
IFU
Rev. 8 (Revision date is 06.2019)
Rev. 9 (Revision date is 09.2020)
CE
CE Pro HP
DoC
DoC Pro HP
BMS – Avantgarde™
IFU
IFU_IC0710.137.105 Issued Rev. 9 ( Revision date is 01.2020)
IFU_IC0710.137.105 Issued Rev.10 ( Revision date is 04.2021)
CE
CE Avantgarde™
DoC
DoC Avantgarde™
BMS – Commander™
IFU
Rev.13 (Revision date is 06.2021)
BMS – Ephesos II
IFU
Rev.12 (Revision date is 05.2021)
Catheter – Alviguide™ Blue+
IFU
Rev.6 (Revision date is 09.2020)
CE
CE - Alviguide Blue+ for 93-42-EEC (MDD)
Extension Letter-EU 2023-603
DoC
DoC Alviguide Blue+ for 93-42-EEC (MDD)
Catheter – Alvision
IFU
Rev.12 (Revision date is 05.2022)
Rev.13 (Revision date is 07.2022)
Rev.00 (Revision date is 03.2023)_EU 2017-745
Leaflet Rev.00 (Revision date is 31.08.2023) EU 2017-745
CE
CE - Alvision for 93-42-EEC (MDD)
Extension Letter-EU 2023-603
CE - Alvision for EU 2017-745 (MDR)
DoC
DoC Alvision for 93-42-EEC (MDD)
DoC Alvision for EU 2017-745 (MDR)
