This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the nit-occlud® pda. This device is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimumangiographic diameter less than 4 mm.
| Device | NIT-OCCLUD PDA |
| Classification Name | Occluder, Patent Ductus, Arteriosus |
| Generic Name | Occluder, Patent Ductus, Arteriosus |
| Applicant | PFM MEDICAL, INC |
| Date Received | 2012-05-04 |
| Decision Date | 2013-08-16 |
| Notice Date | 2013-08-26 |
| PMA | P120009 |
| Supplement | S |
| Product Code | MAE |
| Docket Number | 13M-0988 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PFM MEDICAL, INC 1916 Palomar Oaks Way suite 150 carlsbad, CA 92008 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120009 | Original Filing | |
| S003 | 2016-10-12 | Normal 180 Day Track No User Fee |
| S002 | 2014-12-10 | 30-day Notice |
| S001 | 2014-05-05 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 4042301160027 | P120009 | 000 |
| 04042301159939 | P120009 | 000 |
| 4042301160041 | P120009 | 003 |
| 4042301160003 | P120009 | 003 |
| 4042301159984 | P120009 | 003 |
| 4042301159960 | P120009 | 003 |