PMA P890061S017
- Device
- SUPERIOR VENA CAVA LEAD
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S017
- Product code
- LWS
- Decision date
- 2010-01-12
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- SUPERIOR VENA CAVA LEAD
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S017
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2010-01-12
- Decision code
- OK30
- Date received
- 2009-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.