PMA P000020S013
- Device
- Stinger/stringer S/stinger M/stinger Sm/scorpion/s
- Applicant
- Boston Scientific Corp.
- PMA number
- P000020
- Supplement
- S013
- Decision date
- 2010-01-21
Current openFDA PMA Record
- Device
- STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS
- Applicant
- Boston Scientific Corp
- PMA number
- P000020
- Supplement
- S013
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2010-01-21
- Decision code
- APPR
- Date received
- 2010-01-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF A WARNING TO THE INSTRUCTIONS FOR USE STATING: ¿REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT.¿