ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD
FDA premarket approval P960040/S353 · decided 2015-08-21
Approval details
- PMA number
- P960040
- Supplement
- S353
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-07-29
- Decision date
- 2015-08-21
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF AN ALTERNATE SEMI-AUTOMATED 'THICKNESS AND LOADING' PROCESS STEP TO THE BATTERY MANUFACTURING LINE.
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