Brand Name | AMPLATZER SEPTAL OCCLUDER |
Type of Device | TRANSCATHETER SEPTAL OCCLUDER |
Manufacturer (Section D) |
AGA MEDICAL CORPORATION |
5050 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
AGA MEDICAL CORPORATION |
5050 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
stephanie
o' sullivan
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 8708471 |
MDR Text Key | 148321073 |
Report Number | 2135147-2019-00173 |
Device Sequence Number | 1 |
Product Code |
MLV
|
UDI-Device Identifier | 00811806010045 |
UDI-Public | 00811806010045 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/03/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2021 |
Device Model Number | 9-ASD-007 |
Device Catalogue Number | 9-ASD-007 |
Device Lot Number | 5707216 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/23/2019
|
Initial Date FDA Received | 06/18/2019 |
Supplement Dates Manufacturer Received | 09/29/2019
|
Supplement Dates FDA Received | 10/03/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/29/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 24 YR |