ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P960040/S356 · decided 2015-10-19
Approval details
- PMA number
- P960040
- Supplement
- S356
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-09-23
- Decision date
- 2015-10-19
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CONVERT ONE SUPER OUTPUT MODULE (SOM) TO ANOTHER SOM BY SUBJECTING IT TO A TEMPERATURE CYCLE SCREENING PROCESS.
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