PMA P860019S260
- Device
- PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX)
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S260
- Product code
- LOX
- Decision date
- 2010-09-01
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.
Current openFDA PMA Record#
- Device
- PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX)
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S260
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-09-01
- Decision code
- OK30
- Date received
- 2010-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.