TherOx DownStream System
FDA premarket approval P170027/S006 · decided 2021-12-09
Approval details
- PMA number
- P170027
- Supplement
- S006
- 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
- 2021-05-24
- Decision date
- 2021-12-09
- Days to decision
- 199 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) protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.