INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
FDA premarket approval P960040/S258 · decided 2012-05-18
Approval details
- PMA number
- P960040
- Supplement
- S258
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-04-27
- Decision date
- 2012-05-18
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO AN EXISTING MANUFACTURING PROCESS.
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