Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01870869
Status:
TERMINATED
Last Update Posted:
2020-06-22
First Post:
2013-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Sponsor:
Allergan
Organization:
Study Overview
Official Title:
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: