SJM ACTIVE & PASSIVE LEADS
FDA premarket approval P960030/S015 · decided 2009-11-19
Approval details
- PMA number
- P960030
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SJM ACTIVE & PASSIVE LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-02-26
- Decision date
- 2009-11-19
- Days to decision
- 997 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A MINOR PROCESS CHANGE TO AN SJM VENDOR IN THE MANUFACTURE OF SJM ACTIVE AND PASSIVE LEADS.
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