NIT-OCCLUD SYSTEM
FDA premarket approval P120009/S002 · decided 2015-01-21
Approval details
- PMA number
- P120009
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NIT-OCCLUD SYSTEM
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- Pfm Medical, Inc.
- Date received
- 2014-12-10
- Decision date
- 2015-01-21
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- ADDITION OF A NEW PIECE OF EQUIPMENT FOR A MANUFACTURING PROCESS INVOLVING COILING OF WIRE.
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