PMA P900043S016
- Device
- Palmaz-schatz Minicrown Balloon-expandable Stent W
- Applicant
- CORDIS CORP.
- PMA number
- P900043
- Supplement
- S016
- Decision date
- 1999-05-27
Current openFDA PMA Record
- Device
- PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S016
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-05-27
- Decision code
- APPR
- Date received
- 1999-05-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a label to the outside front panel of the MiniCrown carton that states the following: "Do not induce a vacuum on the delivery system prior to reaching the target lesion."