PMA P900043S013
- Device
- Palmaz-schatz Minicrown Balloon-expandable Stent W
- Applicant
- CORDIS CORP.
- PMA number
- P900043
- Supplement
- S013
- Decision date
- 1999-04-15
Current openFDA PMA Record
- Device
- PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S013
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-04-15
- Decision code
- APPR
- Date received
- 1998-11-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the PALMAZ-SCHATZ(TM) MiniCrown Balloon Expandable Stent with Dynasty(TM) Over the Wire Delivery System (11 mm and 15 mm stent lengths with 2.25, 2.50, 2.75, 3.00, and 3.25 mm balloon diameters). The device is indicated for improving coronary luminal diameter in the following: Treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions (< 25mm) with a reference vessel diameters in the range of 2.25 to 3.25mm. Long term outcome (beyond 1 month) for this permanent implant is unknown at present.