PMA NIT-OCCLUD PDA
FDA premarket approval P120009/S003 · decided 2016-12-16
Approval details
- PMA number
- P120009
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PMA NIT-OCCLUD PDA
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- Pfm Medical, Inc.
- Date received
- 2016-10-12
- Decision date
- 2016-12-16
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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