PMA P880003S100
- Device
- PTCA DILATATION & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S100
- Product code
- LOX
- Decision date
- 2010-01-20
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- ALTERNATE MANUFACTURING FACILITY FOR AN EXTRUSION PROCESS.
Current openFDA PMA Record
- Device
- PTCA DILATATION & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S100
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-01-20
- Decision code
- OK30
- Date received
- 2009-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE MANUFACTURING FACILITY FOR AN EXTRUSION PROCESS.