ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM
FDA premarket approval P020018/S013 · decided 2006-10-17
Approval details
- PMA number
- P020018
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2006-09-18
- Decision date
- 2006-10-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- TRANSFER THE CUTTING, SANDBLASTING, AND CHAMFERING STEPS USED TO MANUFACTURE THE THREADED CANNULA (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) FROM COOK, INC. TO AN OUTSIDE VENDOR.
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