PMA P110004S023
- Device
- NIRTRAKS Clinical Study
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S023
- Product code
- MAF
- Decision date
- 2017-11-01
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- NIRTRAKS Clinical Study
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S023
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-11-01
- Decision code
- APPR
- Date received
- 2017-06-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for revised protocol for the post-approval study (PAS) protocol.