PRECISE NITINOL STENT SYSTEMS
FDA premarket approval P030047/S028 · decided 2015-04-16
Approval details
- PMA number
- P030047
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISE NITINOL STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2015-03-18
- Decision date
- 2015-04-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- REMOVAL OF A REDUNDANT MANUFACTURING IN-PROCESS WATERBORNE TESTING STEP USED IN THE STENT CLEANING PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.