RES-Q(TM) MICRON ICD SYSTEM
FDA premarket approval P940008/S006 · decided 1997-08-13
Approval details
- PMA number
- P940008
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1997-07-25
- Decision date
- 1997-08-13
- Days to decision
- 19 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- THIS SUPPLEMENT CONTAINS THE CHANGES TO A DOCUMENT THAT WAS ORIGINALLY SUBMITTED WITH THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) SUPPLEMENT APPLICATION G950212/S8. THE IDE SUPPLEMENT REQUESTED TO CLOSE THE CLINICAL INVESTIGATION OF RES-Q II ACD DEVICES. SINCE THE IDE WAS OFFICIALLY CLOSED, FDA RECOMMENDED TO USE THIS PMA SUPPLEMENT AS AN ADMINISTRATIVE VEHICLE TO ADDRESS THE DEAR DOCTOR LETTER THAT WAS PREVIOUSLY SUBMITTED AS PART OF THE IDE SUPPLEMENT. FDA ACKNOWLEDGES THAT ALTHOUGH THE ABOVE I
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