DYNAGEN ICD, INOGEN ICD, ORIGEN ICD
FDA premarket approval P960040/S359 · decided 2015-12-07
Approval details
- PMA number
- P960040
- Supplement
- S359
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN ICD, INOGEN ICD, ORIGEN ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-11-09
- Decision date
- 2015-12-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A NEW MANUFACTURING INSPECTION TO VERIFY THE POLARITY OF THE DISCRETE CAPACITOR ARRAY COMPONENT ON THE PRINTED CIRCUIT BOARD.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.