PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFELX OPTIM FAMILIES OF LEADS
FDA premarket approval P960030/S027 · decided 2009-09-25
Approval details
- PMA number
- P960030
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFELX OPTIM FAMILIES OF LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-08-28
- Decision date
- 2009-09-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE IN TEMPERATURE AND HUMIDITY CURE OPERATION.
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