PMA P970035S018
- Device
- S540 OVER THE WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S018
- Product code
- MAF
- Decision date
- 1999-12-22
- Generic name
- STENT, CORONARY
- Approval order statement
- Manufacturing changes being made to the inner member necking process
Current openFDA PMA Record
- Device
- S540 OVER THE WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S018
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-12-22
- Decision code
- OK30
- Date received
- 1999-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes being made to the inner member necking process