PMA P040040S041
- Device
- AMPLATZER Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- Product code
- MLV
- Decision date
- 2020-10-06
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval for a process change in the manufacture of the polyester used in the AMPLATZER device family.
Current openFDA PMA Record#
- Device
- AMPLATZER Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S041
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2020-10-06
- Decision code
- APPR
- Date received
- 2020-04-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a process change in the manufacture of the polyester used in the AMPLATZER device family.