PMA P110004S025
- Device
- NIRxcell CoCr Coronary Stent on RX System
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S025
- Product code
- MAF
- Decision date
- 2017-09-19
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Removal of the redundant supplier seal peel test for the sterilization pouch.
Current openFDA PMA Record#
- Device
- NIRxcell CoCr Coronary Stent on RX System
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S025
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-09-19
- Decision code
- OK30
- Date received
- 2017-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the redundant supplier seal peel test for the sterilization pouch.