ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM
FDA premarket approval P060033/S057 · decided 2010-09-01
Approval details
- PMA number
- P060033
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2010-08-02
- Decision date
- 2010-09-01
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE TO STERILIZATION LOAD CONFIGURATION.
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