PMA P970035S002
- Device
- MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S002
- Product code
- MAF
- Decision date
- 1998-02-23
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for a manufacturing site located at 3576 Unocal Place, Bldg. B, Santa Rosa, CA and 7975 Cameron Drive (extrusion) Windsor, CA.
Current openFDA PMA Record
- Device
- MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S002
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1998-02-23
- Decision code
- APPR
- Date received
- 1998-01-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at 3576 Unocal Place, Bldg. B, Santa Rosa, CA and 7975 Cameron Drive (extrusion) Windsor, CA.