PMA P970035S007
- Device
- MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S007
- Product code
- MAF
- Decision date
- 1998-09-30
- Generic name
- STENT, CORONARY
- Approval order statement
- Requested a change in the current balloon bond process from a manual to an automated process.
Current openFDA PMA Record#
- Device
- MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S007
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1998-09-30
- Decision code
- OK30
- Date received
- 1998-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Requested a change in the current balloon bond process from a manual to an automated process.