INTEGRITY CORONARY STENT SYSTEMS
FDA premarket approval P030009/S063 · decided 2013-04-12
Approval details
- PMA number
- P030009
- Supplement
- S063
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTEGRITY CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2013-03-14
- Decision date
- 2013-04-12
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR AN UPDATE TO THE PRODUCT LABELING TO ADD THE ACRONYM 'BMS' TO THE INTEGRITY PRODUCT AND 'DES' TO THE RESOLUTE INTEGRITY PRODUCT TO THE DEVICE'S LUER.
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