CORDIS S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S035 · decided 2015-11-05
Approval details
- PMA number
- P020036
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2015-10-05
- Decision date
- 2015-11-05
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- A CHANGE TO THE MANUFACTURING LOCATION OF YOUR SUPPLIER FOR THE INTERNAL PACKAGING POUCHES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.