PMA P030009S092
- Device
- Integrity Coronary Stent Systems
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S092
- Product code
- MAF
- Decision date
- 2017-10-04
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for a material change to the distal inner shaft of the Integrity Coronary Stent Systems (RX & OTW).
Current openFDA PMA Record#
- Device
- Integrity Coronary Stent Systems
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S092
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-10-04
- Decision code
- APPR
- Date received
- 2017-07-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to the distal inner shaft of the Integrity Coronary Stent Systems (RX & OTW).