PMA P110004S018
- Device
- NIRxcell CoCr Coronary Stent on RX System
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S018
- Product code
- MAF
- Decision date
- 2017-04-26
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for modifications to the NIRxcell CoCr Coronary Stent on RX System.
Current openFDA PMA Record#
- Device
- NIRxcell CoCr Coronary Stent on RX System
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S018
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-04-26
- Decision code
- APPR
- Date received
- 2016-07-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the NIRxcell CoCr Coronary Stent on RX System.