PMA P110004S012
- Device
- NIRXCELL COCR CORONARY STENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S012
- Product code
- MAF
- Decision date
- 2015-09-03
- Generic name
- STENT, CORONARY
- Approval order statement
- CHANGE TO DECREASE THE CRIMPING AND PRE-CRIMPING FORCES IN THE 3.5X 24MM AND 4.0 X 08MM STENT SIZES.
Current openFDA PMA Record#
- Device
- NIRXCELL COCR CORONARY STENT ON RX SYSTEM
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S012
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2015-09-03
- Decision code
- OK30
- Date received
- 2015-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO DECREASE THE CRIMPING AND PRE-CRIMPING FORCES IN THE 3.5X 24MM AND 4.0 X 08MM STENT SIZES.