PMA P860019S237
- Device
- APEX PTCA BALLOON DILITATION CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S237
- Product code
- LOX
- Decision date
- 2009-09-22
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR CHANGES TO THE BONDING PROCESS.
Current openFDA PMA Record#
- Device
- APEX PTCA BALLOON DILITATION CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S237
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-09-22
- Decision code
- APPR
- Date received
- 2009-08-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE BONDING PROCESS.