PMA P120009
- Device
- NIT-OCCLUD PDA
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S003
- Product code
- MAE
- Decision date
- 2024-10-17
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Nit-Occlud PDA PAS Study
Current openFDA PMA Record#
- Device
- NIT-OCCLUD PDA
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S004
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2024-10-17
- Decision code
- APPR
- Date received
- 2023-01-12
- 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 final Post-Approval Study (PAS) Report submitted for the Nit-Occlud PDA PAS Study