PMA P110004S005
- Device
- NIRXCELL COCR CORONARY STENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S005
- Product code
- MAF
- Decision date
- 2014-09-11
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL TO INTRODUCE A SEMI-AUTOMATED HYDROPHILIC COATING PROCESS WHILE RETAINING THE MANUAL PROCESS AS AN ALTERNATE OPTION.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORONARY STENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S005
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-09-11
- Decision code
- APPR
- Date received
- 2014-05-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO INTRODUCE A SEMI-AUTOMATED HYDROPHILIC COATING PROCESS WHILE RETAINING THE MANUAL PROCESS AS AN ALTERNATE OPTION.