ACUITY X4 LEAD
FDA premarket approval P150012/S006 · decided 2016-07-13
Approval details
- PMA number
- P150012
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACUITY X4 LEAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-05-20
- Decision date
- 2016-07-13
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
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