TELIGEN,INCEPTA,PUNCTUA,ENERGEN ICDS, INCEPTA, PUNCTUA,ENERGEN CRT-DS
FDA premarket approval P960040/S312 · decided 2014-05-15
Approval details
- PMA number
- P960040
- Supplement
- S312
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN,INCEPTA,PUNCTUA,ENERGEN ICDS, INCEPTA, PUNCTUA,ENERGEN CRT-DS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-03-18
- Decision date
- 2014-05-15
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES IN TRACE COBALT CONTROL LIMIT IN RAW MNO2 ANDTRACE CALCIUM CONTROL LIMIT IN RAW LITHIUM FOIL FOR THE PULSE GENERATOR BATTERIES.
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