PMA P110023S021
- Device
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S021
- Product code
- NIP
- Decision date
- 2016-11-23
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval to decrease the sample size in the post-approval study protocol.
Current openFDA PMA Record#
- Device
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P110023
- Supplement
- S021
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2016-11-23
- Decision code
- APPR
- Date received
- 2016-09-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval to decrease the sample size in the post-approval study protocol.