PMA P890061S019
- Device
- VENTAK/VENTAK P/VENTAK P2 FAMILIES
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S019
- Product code
- LWS
- Decision date
- 2011-04-29
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- VENTAK/VENTAK P/VENTAK P2 FAMILIES
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S019
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-04-29
- Decision code
- OK30
- Date received
- 2011-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.