PMA P000039S083
- Device
- Amplatzer™ Septal Occluder; Amplatzer™ Multi-Fenestrated Septal Occluder - Cribriform
- Applicant
- ABBOTT MEDICAL
- PMA number
- P000039
- Supplement
- S083
- Product code
- MLV
- Decision date
- 2025-10-23
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- parametric release for the specified chamber/cycle at Steris AST (Minneapolis, MN).
Current openFDA PMA Record#
- Device
- Amplatzer™ Septal Occluder; Amplatzer™ Multi-Fenestrated Septal Occluder - Cribriform
- Applicant
- ABBOTT MEDICAL
- PMA number
- P000039
- Supplement
- S083
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2025-10-23
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- parametric release for the specified chamber/cycle at Steris AST (Minneapolis, MN).