ISOFLEX LEAD FAMILY
FDA premarket approval P960030/S014 · decided 2007-03-08
Approval details
- PMA number
- P960030
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISOFLEX LEAD FAMILY
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-02-08
- Decision date
- 2007-03-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- MODIFY THE CRIMPING PROCESS FOR THE CONNECTOR RING ON ISOFLEX LEADS.
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