INGEVITY LEAD
FDA premarket approval P150012/S009 · decided 2016-07-25
Approval details
- PMA number
- P150012
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY LEAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-06-27
- Decision date
- 2016-07-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change in a reactant used for preparation of the key intermediate in the synthesis of dexamethasone acetate.
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