PMA P860019S232
- Device
- APEX PTCA DILATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S232
- Product code
- LOX
- Decision date
- 2010-02-01
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL TO MODIFY THE SAMPLING FREQUENCIES AND ACCEPTANCE LIMITS ASSOCIATED WITH DESTRUCTIVE TESTS.
Current openFDA PMA Record#
- Device
- APEX PTCA DILATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S232
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-02-01
- Decision code
- APPR
- Date received
- 2009-03-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MODIFY THE SAMPLING FREQUENCIES AND ACCEPTANCE LIMITS ASSOCIATED WITH DESTRUCTIVE TESTS.