PMA P990036
- Device
- Cordis Checkmate(tm) System
- Applicant
- CORDIS CORP.
- PMA number
- P990036
- Decision date
- 2000-11-03
Current openFDA PMA Record
- Device
- CORDIS CHECKMATE SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P990036
- Supplement
- S003
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2002-07-25
- Decision code
- APPR
- Date received
- 2002-06-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE REGARDING THE RECOILING OF THE SOURCE RIBBON ON THE SPOOL OF THE DELIVERY DEVICE AND THE USE OF THE METAL CAPS ON THE ENDS OF THE DELIVERY DEVICE.