SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL
FDA premarket approval P110042/S033 · decided 2014-05-28
Approval details
- PMA number
- P110042
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Trade name
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-05-05
- Decision date
- 2014-05-28
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- TRANSFER THE FINAL PACKAGE FOR THE EIT FROM CAMERON TO CAMERONS CONTRACT MANUFACTURER BOSTON SCIENTIFIC CORPORATION (BSC).
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