PMA P030009S090
- Device
- INTEGRITY CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S090
- Product code
- MAF
- Decision date
- 2016-09-28
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Introducing an upgraded laser ablation machine with integrated automated handling.
Current openFDA PMA Record#
- Device
- INTEGRITY CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S090
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2016-09-28
- Decision code
- OK30
- Date received
- 2016-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introducing an upgraded laser ablation machine with integrated automated handling.