PMA P110004S022
- Device
- NIRxcell CoCr Coronary Stent on RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S022
- Product code
- MAF
- Decision date
- 2017-06-07
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval to introduce a microbiological test to the incoming inspection of the hydrophilic coating solution.
Current openFDA PMA Record#
- Device
- NIRxcell CoCr Coronary Stent on RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S022
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-06-07
- Decision code
- APPR
- Date received
- 2017-05-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to introduce a microbiological test to the incoming inspection of the hydrophilic coating solution.