PMA P110042S033
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S033
- Product code
- LWS
- Decision date
- 2014-05-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- TRANSFER THE FINAL PACKAGE FOR THE EIT FROM CAMERON TO CAMERONS CONTRACT MANUFACTURER BOSTON SCIENTIFIC CORPORATION (BSC).
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S033
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-05-28
- Decision code
- OK30
- Date received
- 2014-05-05
- Supplement type
- 30-Day Notice
- Approval order statement
- TRANSFER THE FINAL PACKAGE FOR THE EIT FROM CAMERON TO CAMERONS CONTRACT MANUFACTURER BOSTON SCIENTIFIC CORPORATION (BSC).