TELIGEN, INCEPTA, ENERGEN, PUNCTUA IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR
FDA premarket approval P960040/S272 · decided 2012-10-17
Approval details
- PMA number
- P960040
- Supplement
- S272
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELIGEN, INCEPTA, ENERGEN, PUNCTUA IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-09-17
- Decision date
- 2012-10-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO THE FINAL HYBRID COMPONENT ELECTRIC TEST AND THE ADDITION OF NEW TEST EQUIPMENT.
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