MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
FDA premarket approval P970035/S002 · decided 1998-02-23
Approval details
- PMA number
- P970035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 1998-01-29
- Decision date
- 1998-02-23
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Approval for a manufacturing site located at 3576 Unocal Place, Bldg. B, Santa Rosa, CA and 7975 Cameron Drive (extrusion) Windsor, CA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759) | Medtronic Ireland | 2026-07-27 |
| Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970) | Medtronic, Ireland | 2026-01-17 |
| Telescope Guide Extension Catheter (K252390) | Medtronic, Ireland | 2025-10-29 |
| Liberant Thrombectomy System (K250787) | Medtronic, Ireland | 2025-06-11 |
| 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 |