NIT-OCCLUD PDA
FDA premarket approval P120009 · decided 2013-08-16
Approval details
- PMA number
- P120009
- Trade name
- NIT-OCCLUD PDA
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- Pfm Medical, Inc.
- Date received
- 2012-05-04
- Decision date
- 2013-08-16
- Days to decision
- 469 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- 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.
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