PMA P120009S001
- Device
- NIT-OCCLUD PDA
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S001
- Product code
- MAE
- Decision date
- 2014-08-01
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- NIT-OCCLUD PDA
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S001
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2014-08-01
- Decision code
- APPR
- Date received
- 2014-05-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.