CORDIS PALMAZ BALLOON EXPANDABLE STENTS
FDA premarket approval P890017/S011 · decided 2003-07-15
Approval details
- PMA number
- P890017
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS PALMAZ BALLOON EXPANDABLE STENTS
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 2003-04-15
- Decision date
- 2003-07-15
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.