ORIGEN EL,ORIGEN MINI, INOGEN EL,INOGEN MINI, DYNAGEN EL,DYNAGEN MINI, INCEPTA, ENERGEN, PUNCTUA ICDS
FDA premarket approval P960040/S333 · decided 2014-10-16
Approval details
- PMA number
- P960040
- Supplement
- S333
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN EL,ORIGEN MINI, INOGEN EL,INOGEN MINI, DYNAGEN EL,DYNAGEN MINI, INCEPTA, ENERGEN, PUNCTUA ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-09-17
- Decision date
- 2014-10-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- VERTICALLY INTEGRATE THE MANUFACTURE OF THE SPRING CONTACTS USED IN THE HEADER COMPONENTS OF THE DEVICES.
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