ISOFLEX (ISOFLEX S, ISOFLEX P, ISOFLEX OPTIM) AND PASSIVE PLUS FAMILY OF LEADS
FDA premarket approval P960030/S036 · decided 2012-05-03
Approval details
- PMA number
- P960030
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Trade name
- ISOFLEX (ISOFLEX S, ISOFLEX P, ISOFLEX OPTIM) AND PASSIVE PLUS FAMILY OF LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-04-03
- Decision date
- 2012-05-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
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