PMA P030009S096
- Device
- Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S096
- Product code
- MAF
- Decision date
- 2020-06-02
- Generic name
- STENT, CORONARY
- Approval order statement
- Introduction of an upgraded pouch sealer to the manufacturing process.
Current openFDA PMA Record#
- Device
- Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S096
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2020-06-02
- Decision code
- OK30
- Date received
- 2020-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an upgraded pouch sealer to the manufacturing process.