SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
FDA premarket approval P110042/S004 · decided 2013-02-21
Approval details
- PMA number
- P110042
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2013-01-11
- Decision date
- 2013-02-21
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A CHANGE TO THE PATIENT SCREENING INSTRUCTIONS IN THE SQ-RX PULSE GENERATOR USER MANUAL.
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