PMA P040040S048
- Device
- Amplatzer™ Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S048
- Product code
- MLV
- Decision date
- 2024-11-01
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval for modifications to the Instructions for Use to reflect the findings of the MuVSD study
Current openFDA PMA Record#
- Device
- Amplatzer™ Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S048
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-11-01
- Decision code
- APPR
- Date received
- 2024-08-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modifications to the Instructions for Use to reflect the findings of the MuVSD study