PMA P120009S002
- Device
- NIT-OCCLUD SYSTEM
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S002
- Product code
- MAE
- Decision date
- 2015-01-21
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- ADDITION OF A NEW PIECE OF EQUIPMENT FOR A MANUFACTURING PROCESS INVOLVING COILING OF WIRE.
Current openFDA PMA Record#
- Device
- NIT-OCCLUD SYSTEM
- Applicant
- Pfm Medical, Inc.
- PMA number
- P120009
- Supplement
- S002
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2015-01-21
- Decision code
- OK30
- Date received
- 2014-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW PIECE OF EQUIPMENT FOR A MANUFACTURING PROCESS INVOLVING COILING OF WIRE.