ISOFLEX S LEADS
FDA premarket approval P960030/S016 · decided 2007-05-09
Approval details
- PMA number
- P960030
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISOFLEX S LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-03-05
- Decision date
- 2007-05-09
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LEAD INSULATION WALL THICKNESS AND LENGTH, AS WELL AS A CHANGE TO THE OUTER COIL EXIT ANGLE.
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