ENDEAVOR SPRINT CORONARY STENT SYSTEMS
FDA premarket approval P060033/S068 · decided 2011-10-19
Approval details
- PMA number
- P060033
- Supplement
- S068
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDEAVOR SPRINT CORONARY STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic, Inc.
- Date received
- 2011-09-26
- Decision date
- 2011-10-19
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGING THE PRODUCT PRINT INFORMATION FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
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