TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
FDA premarket approval P960040/S267 · decided 2012-08-22
Approval details
- PMA number
- P960040
- Supplement
- S267
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-07-25
- Decision date
- 2012-08-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD AN AUTOMATIC OPTICAL INSPECTION (AOI) SYSTEM USED TO INSPECT COMPONENT PLACED ON THE PRINTED CIRCUIT BOARD.
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