DYNAGEN,INOGEN,ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
FDA premarket approval P960040/S315 · decided 2014-05-23
Approval details
- PMA number
- P960040
- Supplement
- S315
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN,INOGEN,ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-05-05
- Decision date
- 2014-05-23
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
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