ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
FDA premarket approval P060033/S025 · decided 2008-12-16
Approval details
- PMA number
- P060033
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2008-11-17
- Decision date
- 2008-12-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- EQUIPMENT MODIFICATION TO THE SPRAY MACHINE USED TO APPLY THE DRUG COATING LAYER TO THE DEVICES.
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