INTEGRITY CORONARY STENT SYSTEMS
FDA premarket approval P030009/S067 · decided 2013-09-18
Approval details
- PMA number
- P030009
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTEGRITY CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2013-08-19
- Decision date
- 2013-09-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGE TO THE LABELING INSPECTION PROCESS.
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