TherOx DownStream System
FDA premarket approval P170027/S016 · decided 2024-12-11
Approval details
- PMA number
- P170027
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TherOx DownStream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2024-11-18
- Decision date
- 2024-12-11
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- partial relocation of Catheter manufacturing process steps and process improvement in current bioburden monitoring process
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