INTEGRITY CORONARY STENT SYSTEM
FDA premarket approval P030009/S058 · decided 2011-09-07
Approval details
- PMA number
- P030009
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTEGRITY CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2011-08-08
- Decision date
- 2011-09-07
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL TO MODIFY THE MAXIMUM STENT INNER DIAMETER (MSID) FOR THE MEDIUM VESSEL STENT SIZES (3.0 MM TO 4.0 MM DIAMETERS) FROM 4.75 MM TO 5.0 MM.
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