ISOFLEX OPTIM LEADS
FDA premarket approval P960030/S020 · decided 2008-03-18
Approval details
- PMA number
- P960030
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISOFLEX OPTIM LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-01-17
- Decision date
- 2008-03-18
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR DEVICE MODIFICATIONS TO THE ISOFLEX OPTIM FAMILY OF LEADS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ISOFLEX OPTIM MODEL 1944T AND ISOFLEX OPTIM 1948T.
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