PMA P110004S003
- Device
- NIRXCELL COCR CORONARY SENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S003
- Product code
- MAF
- Decision date
- 2014-05-12
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- ADDITION OF A NEW CLEAN ROOM TO THE MEDINOL JERUSALEM MANUFACTURING PLANT.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORONARY SENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S003
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-05-12
- Decision code
- OK30
- Date received
- 2014-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW CLEAN ROOM TO THE MEDINOL JERUSALEM MANUFACTURING PLANT.