PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS
FDA premarket approval P960030/S031 · decided 2015-08-13
Approval details
- PMA number
- P960030
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Trade name
- PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-05-20
- Decision date
- 2015-08-13
- Days to decision
- 1911 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
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