CONNECTOR SLEEVE ACCESSORY KIT
FDA premarket approval P030054/S192 · decided 2011-08-05
Approval details
- PMA number
- P030054
- Supplement
- S192
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONNECTOR SLEEVE ACCESSORY KIT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-06-20
- Decision date
- 2011-08-05
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A CONNECTOR SLEEVE ACCESSORY KIT MODEL EX3151. THE CONNECTOR SLEEVE IS INDICATED FOR USE WITH IS-4 AND DF-4 LEAD CONNECTORS TO FACILITATE THE CONNECTION TO A PACING SYSTEM ANALYZER AT THE TIME OF IMPLANT.
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