PMA P830060S088
- Device
- Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S088
- Product code
- LWS
- Decision date
- 2022-11-02
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Replace laser printers, finished goods box and tray label stock.
Current openFDA PMA Record#
- Device
- Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S088
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-11-02
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace laser printers, finished goods box and tray label stock.