Durata and Optisure HV leads
FDA premarket approval P030054/S330 · decided 2017-07-26
Approval details
- PMA number
- P030054
- Supplement
- S330
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durata and Optisure HV leads
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-06-27
- Decision date
- 2017-07-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Addition of a curing oven during the connector assembly solvent bond process.
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