PMA P110004S011
- Device
- NIRXCELL COCR CORONARY STENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S011
- Product code
- MAF
- Decision date
- 2015-03-17
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR A PATIENT IMPLANT CARD.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORONARY STENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S011
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2015-03-17
- Decision code
- APPR
- Date received
- 2015-02-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A PATIENT IMPLANT CARD.