PMA P900043S009
- Device
- PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S009
- Product code
- MAF
- Decision date
- 1998-06-24
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for addition of the patient manual titled "Understanding Coronary Artery Disease and your Stent: A Guide for Patients.".
Current openFDA PMA Record
- Device
- PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S009
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1998-06-24
- Decision code
- APPR
- Date received
- 1998-03-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for addition of the patient manual titled "Understanding Coronary Artery Disease and your Stent: A Guide for Patients.".