ISOFLEX MODEL 1646T & MODEL 1948T (OPTIM) LOW VOLTAGE LEADS
FDA premarket approval P960030/S033 · decided 2011-05-05
Approval details
- PMA number
- P960030
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISOFLEX MODEL 1646T & MODEL 1948T (OPTIM) LOW VOLTAGE LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-04-04
- Decision date
- 2011-05-05
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE SUPPLIER FOR THE INNER AND OUTER COILS USED TO MANUFACTURE LOW VOLTAGE LEADS.
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