PMA P860019S235
- Device
- APEX PTCA BALLOON DILATION CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S235
- Product code
- LOX
- Decision date
- 2009-05-13
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- CHANGE TO THE SUPPLIER OF THE OVER-THE-WIRE MANIFOLD COMPONENT.
Current openFDA PMA Record#
- Device
- APEX PTCA BALLOON DILATION CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S235
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-05-13
- Decision code
- OK30
- Date received
- 2009-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SUPPLIER OF THE OVER-THE-WIRE MANIFOLD COMPONENT.