INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS
FDA premarket approval P960040/S311 · decided 2014-03-31
Approval details
- PMA number
- P960040
- Supplement
- S311
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-03-14
- Decision date
- 2014-03-31
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ALTERNATE PROCESS FOR EXCISING THE PRINTED CIRCUIT BOARDS (PCB) FROM THE PCB PANEL USING A LASER EXCISE SYSTEM.
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