CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM
FDA premarket approval P030047/S003 · decided 2007-07-12
Approval details
- PMA number
- P030047
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2007-04-16
- Decision date
- 2007-07-12
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE CORDIS PRECISE PRO RX NITINOL STENT SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.