PMA P110004S010
- Device
- NIRXCELL COCR-CORONARY STENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S010
- Product code
- MAF
- Decision date
- 2015-05-14
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR-CORONARY STENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S010
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2015-05-14
- Decision code
- APPR
- Date received
- 2014-11-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.