ZENITH FLEX AAA ENDOVASCULAR GRAFT & ZENITH RENU AAA ANCILLARY GRAFT WITH Z-TRAK INTRODUCTION SYSTEM
FDA premarket approval P020018/S036 · decided 2010-07-15
Approval details
- PMA number
- P020018
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZENITH FLEX AAA ENDOVASCULAR GRAFT & ZENITH RENU AAA ANCILLARY GRAFT WITH Z-TRAK INTRODUCTION SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2010-06-18
- Decision date
- 2010-07-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- ADDITION OF A QUALITY CONTROL TEST TO THE CAPTOR HEMOSTATIC VALVE TUBING SUBASSEMBLY PROCESS.
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