TherOx Downstream System
FDA premarket approval P170027/S018 · decided 2026-04-10
Approval details
- PMA number
- P170027
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TherOx Downstream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2025-03-11
- Decision date
- 2026-04-10
- Days to decision
- 395 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- approval of the revised protocol for the post-approval study (PAS)
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