PMA P860019S225
- Device
- BOSTON SCIENTIFIC QUANTUM MAVERICK PTCA DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S225
- Product code
- LOX
- Decision date
- 2008-07-03
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR MINOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE FOR THE QUANTUM MAVERICK PTCA CATHETERS.
Current openFDA PMA Record#
- Device
- BOSTON SCIENTIFIC QUANTUM MAVERICK PTCA DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S225
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2008-07-03
- Decision code
- APPR
- Date received
- 2008-05-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MINOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE FOR THE QUANTUM MAVERICK PTCA CATHETERS.