Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714385
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2021-01-14
Brief Title:
Medtronic PSR TDD PMCF
Sponsor:
Medtronic
Organization:
Medtronic
Study Overview
Official Title:
Product Surveillance Registry PSR - Targeted Drug Delivery TDD - SynchroMed II European Post-Market Clinical Follow-up PMCF
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use Data will support post-market surveillance obligations
Detailed Description:
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None