- Device
- Amplatzer Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S045
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2022-01-13
- Decision code
- APPR
- Date received
- 2021-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.