Integrity Coronary Stent System
FDA premarket approval P030009/S100 · decided 2021-03-12
Approval details
- PMA number
- P030009
- Supplement
- S100
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Integrity Coronary Stent System
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2021-03-04
- Decision date
- 2021-03-12
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.
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510(k) clearances by this applicant
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|---|---|---|
| Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759) | Medtronic Ireland | 2026-07-27 |
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| ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT (K123153) | Medtronic, Ireland | 2013-04-09 |
| SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095) | Medtronic, Ireland | 2010-10-22 |
| ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480) | Medtronic, Ireland | 2006-08-21 |
| ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431) | Medtronic, Ireland | 2006-03-16 |