INGEVITY LEADS
FDA premarket approval P150012/S025 · decided 2017-01-18
Approval details
- PMA number
- P150012
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY LEADS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-12-21
- Decision date
- 2017-01-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Updates to the software, equipment, and process steps for bond sealing.
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