CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS
FDA premarket approval P020036/S034 · decided 2015-05-28
Approval details
- PMA number
- P020036
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2015-05-01
- Decision date
- 2015-05-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.