PMA P110004S021
- Device
- NIRXCELL PMS US STUDY NIRTRAKS
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S021
- Product code
- MAF
- Decision date
- 2017-02-10
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for cessation of patient enrollment in this PAS for the post-approval study (PAS).
Current openFDA PMA Record#
- Device
- NIRXCELL PMS US STUDY NIRTRAKS
- Applicant
- Medinol, Ltd.
- PMA number
- P110004
- Supplement
- S021
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-02-10
- Decision code
- APPR
- Date received
- 2016-12-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for cessation of patient enrollment in this PAS for the post-approval study (PAS).