PMA P110004S015
- Device
- NIRXCELL COCR CORONARYSTENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S015
- Product code
- MAF
- Decision date
- 2017-08-07
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for labeling updates to the Instructions for Use (IFU) to reflect the long-term data from the Post-Approval BLAST Placebo Cohort study.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORONARYSTENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S015
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-08-07
- Decision code
- APPR
- Date received
- 2015-12-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling updates to the Instructions for Use (IFU) to reflect the long-term data from the Post-Approval BLAST Placebo Cohort study.