PMA P970035S010
- Device
- GFX OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S010
- Product code
- MAF
- Decision date
- 1998-11-17
- Generic name
- STENT, CORONARY
- Approval order statement
- The 30-day Notice requested a change in the current Secure Strain Relief Process et temperature from 300 degrees F to 260 degrees F in order to optimize the process.
Current openFDA PMA Record
- Device
- GFX OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S010
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1998-11-17
- Decision code
- OK30
- Date received
- 1998-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day Notice requested a change in the current Secure Strain Relief Process et temperature from 300 degrees F to 260 degrees F in order to optimize the process.