SMART AND SMART CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S031 · decided 2015-07-31
Approval details
- PMA number
- P020036
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SMART AND SMART CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2014-12-19
- Decision date
- 2015-07-31
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NDC, COSTA RICA, S.R.L., EL COYOL ALAJUELA, COSTA RICA, A CONTRACT MANUFACTURER FOR CORDISSMART AND SMART CONTROL NITINOL STENT SYSTEMS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.