PMA P040040S046
- Device
- Amplatzer Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S046
- Product code
- MLV
- Decision date
- 2024-06-26
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- a reduction in the sample size tested for bacterial endotoxins
Current openFDA PMA Record#
- Device
- Amplatzer Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S046
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-06-26
- Decision code
- OK30
- Date received
- 2024-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a reduction in the sample size tested for bacterial endotoxins