ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678
FDA premarket approval P010012/S440 · decided 2016-12-19
Approval details
- PMA number
- P010012
- Supplement
- S440
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2016-11-22
- Decision date
- 2016-12-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Modifications to the primer dry time, molding tool, and molding cure time used to assemble the distal tip of the ACUITY X4 lead body.
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