PMA P830060S075
- Device
- VENTAK
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S075
- Product code
- LWS
- Decision date
- 2013-08-07
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
Current openFDA PMA Record#
- Device
- VENTAK
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S075
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-08-07
- Decision code
- APPR
- Date received
- 2013-05-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.