PMA P110004S016
- Device
- NIRXCELL COCR CORONARY STENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S016
- Product code
- MAF
- Decision date
- 2017-01-31
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval to reduce the sampling frequency for routine product bioburden testing.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORONARY STENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S016
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-01-31
- Decision code
- APPR
- Date received
- 2016-02-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to reduce the sampling frequency for routine product bioburden testing.