ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I
FDA premarket approval P960040/S346 · decided 2015-06-04
Approval details
- PMA number
- P960040
- Supplement
- S346
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-05-18
- Decision date
- 2015-06-04
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.
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