PMA P860019S223
- Device
- QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S223
- Product code
- LOX
- Decision date
- 2008-04-28
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- ALTERNATE MANUFACTURING PROCESS FLOW WHICH ALLOWS FOR THE APPLICATION OF SILICONE COATING TO THE BALLOON BEFORE THE BALLOON WING FORM/FOLD PROCESS.
Current openFDA PMA Record#
- Device
- QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S223
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2008-04-28
- Decision code
- OK30
- Date received
- 2008-03-31
- Supplement type
- 30-Day Notice
- Approval order statement
- ALTERNATE MANUFACTURING PROCESS FLOW WHICH ALLOWS FOR THE APPLICATION OF SILICONE COATING TO THE BALLOON BEFORE THE BALLOON WING FORM/FOLD PROCESS.