PMA P110004S027
- Device
- NIRxcell CoCr Coronary Stent on RX System
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S027
- Product code
- MAF
- Decision date
- 2018-06-07
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for an adjustment of pre-crimping and crimping forces for a single device size.
Current openFDA PMA Record#
- Device
- NIRxcell CoCr Coronary Stent on RX System
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S027
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2018-06-07
- Decision code
- APPR
- Date received
- 2017-12-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an adjustment of pre-crimping and crimping forces for a single device size.