PMA P120009S003
- Device
- PMA NIT-OCCLUD PDA
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S003
- Product code
- MAE
- Decision date
- 2016-12-16
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- PMA NIT-OCCLUD PDA
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S003
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2016-12-16
- Decision code
- APPR
- Date received
- 2016-10-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.