INTEGRITY CORONARY STENT SYSTEMS
FDA premarket approval P030009/S054 · decided 2011-06-09
Approval details
- PMA number
- P030009
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTEGRITY CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2011-04-11
- Decision date
- 2011-06-09
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR ADDITION OF LABELING REGARDING SIMULTANEOUS USE OF THE INTEGRITY RX STENT SYSTEM WITH EITHER ANOTHER INTEGRITY RX STENT SYSTEM, OR WITH A SPRINTER LEGEND RX BALLOON DILATION CATHETER. IN ADDITION, APPROVAL TO REVISE THE MRI COMPATIBILITY INFORMATION IN THE LABELING.
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