PMA P110004S006
- Device
- NIRXCELL COCR CORNARY STENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S006
- Product code
- MAF
- Decision date
- 2014-06-04
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- ELIMINATING A REDUNDANT INSPECTION STEP AND REMOVING AN UNNECESSARY LABELING STEP.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORNARY STENT ON RX
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S006
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-06-04
- Decision code
- OK30
- Date received
- 2014-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATING A REDUNDANT INSPECTION STEP AND REMOVING AN UNNECESSARY LABELING STEP.